Featured Science from ENDO 2020

[madman]

Hypothyroidism patients cite effectiveness in choosing alternative to standard therapy

Three in four hypothyroidism patients who chose desiccated thyroid extract (DTE) over the standard therapy said this option was more effective than other thyroid hormone medications, according to an analysis of comments in online patient forums accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society.

SUN-432: Utilizing Patient Online Forums to Capture Experiences and Perceptions Associated with the Use of Desiccated Thyroid Extract

Background: It is estimated that 10-25% of patients with hypothyroidism use desiccated thyroid extract (DTE) as their primary thyroid hormone replacement medication, despite concerns about the risk of thyrotoxicosis associated with DTE use. It is unclear why many patients prefer the use of DTE as a thyroid hormone replacement formulation over guideline-concordant therapies such as levothyroxine (LT4).

Methods: We conducted a mixed-methods study by analyzing patient-reported information from patient online forums to better understand patient preferences for and attitudes toward the use of DTE to treat hypothyroidism. We searched the 10 most popular patient forums based on number of users (WebMD, Topix, Health questions, Patients like me, Drugs.com, Endocrine Web, Everyday Health, Talk Health Partnership, Spark People and Patients.info) using the key terms: desiccated thyroid extract, desiccated thyroid treatment, thyroid USP, commercial names of DTE (Armour Thyroid® or Natural Thyroid®), thyroid extract, AND hypothyroidism. Unique posts were retrieved from those websites between each forum’s inception to March 2018. From these posts, we extracted descriptive information on patient demographics and clinical characteristics and qualitatively analyzed posts’ content to further explore patient perceptions on DTE and other thyroid hormone replacement therapies.

Results: Unique 1,235 posts were initially retrieved from the included patient forums. After the initial screening, we selected data from three of these forums (WebMD, Patients Like Me, and Drugs.com) based on the completeness of the available information (673 posts). Nearly half (45%) of patients reported that a clinician initially drove their interest in trying DTE. Patients described many reasons for switching from a previous therapeutic approach to DTE, including lack of improvement in symptoms (58%) and the development of side effects (22%). Among a majority of patients, DTE was described as moderately-to-majorly effective overall (81%) and more effective than the previous therapy (77%). The most frequently described benefits associated with DTE use were an improvement in clinical symptoms (56%) as well as a change in overall well-being (34%). One-fifth of patients described side effects related to the use of DTE. Qualitative analysis of posts’ content supported these findings and raised additional issues around the need for individualizing therapy approaches for hypothyroidism as well as difficulties obtaining DTE.

Conclusions: Among patients with hypothyroidism, a subset may prefer DTE over guideline-concordant therapies for many reasons, including perceived effectiveness, despite the risks associated with DTE. Future work should incorporate patient-reported outcomes to better elucidate the mechanisms responsible for therapy preferences in this subset of patients.

 

[madman]

Underactive thyroid more common in people working long hours

Adults who work long hours are more likely to have hypothyroidism, which is an underactive thyroid, according to study results accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society.

SUN-417: Long Working Hours Are Associated with Hypothyroidism: A Cross-Sectional Study with Population-Representative Data

Background: Studies have highlighted the adverse effects of long working hours on workers’ health; however, the association of long working hours with thyroid function has not been studied. This study aimed to assess long working hours as a risk factor for thyroid dysfunction.

Methods: This cross-sectional study was based on data obtained from the Korea National Health and Nutrition Examination Survey conducted from 2013 to 2015. A total of 2,160 adults who worked 36-83 hours per week were included. Thyroid function was defined based on the population thyroid stimulating hormone reference ranges, after excluding individuals with positive results for thyroid peroxidase antibody. The association between working hours and thyroid function was confirmed via multinomial logistic regression.

Results: Hypothyroidism was more prevalent among those with longer working hours (3·5% vs. 1·4% for 53-83 and 36-42 working hours per week, respectively). Individuals who worked longer hours had an increased odds for hypothyroidism (odds ratio 1·46, 95% confidence interval 1·12−1·90, per 10 hour increase in working hours per week), after adjustment for age, sex, body mass index, urine iodine concentration, smoking status, shift work, and socioeconomic characteristics such as occupation, income level, and educational attainment. The association between working hours and hypothyroidism was consistent in various subgroups stratified by sex or socioeconomic characteristics.

Conclusions: To our knowledge, this study is the first to show that long working hours are associated with hypothyroidism. Our findings suggest that appropriate monitoring and treatment of hypothyroidism are necessary among individuals who work long hours.

 

[madman]

Three of the non-invasive methods used to predict who has NASH agree only about 20% of the time

Researchers and clinicians have been trying to find a way to diagnose nonalcoholic steatohepatitis (NASH) without taking a liver tissue biopsy, but according to new research, formulas that aim to predict NASH based on risk factors do not agree with each other and their accuracy varies. The study was accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society.

“The three non-invasive methods we investigated agreed on a NASH diagnosis for only about one-fifth of the participants in the database,” said lead study author Theodore C. Friedman, M.D., Ph.D., chair of the Department of Internal Medicine of Charles R. Drew University of Medicine and Science in Los Angeles, Calif. “These results imply that better methods are needed to predict NASH.”

SUN-606: Identification of NASH Using Data from NHANES III

Further refinement of a noninvasive method for identifying NASH is required. Considerable care must be taken in interpreting risk factors, because the results differ depending which method is used. This could have implications in clinical practice as well, where patients and their risk factors may be mis-identified if formulas are used and not liver biopsy.

 

[madman]

Transgender teens have high rates of depression, suicidal thoughts

Two-thirds of transgender teens have depression, and many also have suicidal thoughts and self-injuring behavior, according to research accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society.

Researchers also found transgender teens had significant improvement in gender dysphoria—the feeling of being uncomfortable with the gender they were assigned—after starting hormone therapy.

SUN-062: Psychiatric Co-Morbidities, Sexual Orientation, and Impact of Therapeutic Interventions in a Gender Non-Conforming Pediatric Practice

Background: There is limited scientific literature regarding gender non-conforming (GNC) youth in pediatric practice. GNC patients of all ages have an increased risk for psychiatric co-morbidities and suicidal risk. An increasing number of GNC youth are seeking therapeutic options to develop physical characteristics to match their gender identity. The study aim is to describe the prevalence of psychiatric co-morbidities and sexual orientation among GNC pediatric patients in a clinic-based setting in Miami, Florida. A secondary aim is to compare the grade of dysphoria before and after therapeutic interventions among GNC youth.

Methods: This is a retrospective chart review on records from 2014-2019 among transgender adolescents attending a pediatric endocrinology clinic in Miami. Data on demographics and clinical characteristics were obtained from electronic medical records. We performed descriptive statistical analysis using SPSS version and reported frequencies and percentages.

Results: A total of 158 patients were included in this analysis. There were 107 (67.7%) affirmed males (female to male), 47 (29.7%) affirmed females (male to female), and 4 (2.5%) considered themselves non-binary. Median age at onset of gender dysphoria symptoms and beginning of social affirmation was earlier in affirmed females (7.21 and 12.36 years vs. 9.65 and 13.50 years). Among affirmed males, sexual orientation was self-reported as 38% straight, 47% bisexual, 12% homosexual and 1% asexual vs. among affirmed females, whose sexual orientation was reported as 54.3% straight, 37.1% bisexual and 8.6% homosexual. Prevalence of psychiatric co-morbidities in our study population was 78.5%. Depression was the most frequent diagnosis (66.5%), followed by anxiety (33.5%), attention deficit hyperactivity disorder (10.1%), bipolar disorder (1.9%), bulimia (1.3%), anorexia nervosa (0.6%) and post traumatic stress disorder (0.6%). Psychiatric co-morbidities were more common among affirmed males (84.1% vs. 66%). History of suicidal ideation was more common among affirmed males (70.1%) than affirmed females (49%). Self-injuring (cutting) was more common among affirmed males (56.1%) than in affirmed females (25.5%). Mean age at hormonal treatment onset was similar in both groups (15.75 years in affirmed males vs. 15.58 years in affirmed females). The degree of gender dysphoria before and after starting hormonal treatment, reported on a scale of 0 (no dysphoria) to 10 (highest possible dysphoria), declined for both genders (8.08/10 and 3.99/10) and affirmed females (7.87/10 and 2.96/10).

Conclusion: The prevalence of psychiatric co-morbidities, suicidal ideation, and self-injuring behavior is high among GNC youth, but in this population, significantly worse among affirmed males. Both groups had significant improvement in the degree of dysphoria after beginning hormonal treatment.

 

[madman]

Two types of diabetes drugs similarly effective in reducing heart and kidney disease

Two newer types of medications commonly used to treat type 2 diabetes are similar in their ability to reduce major heart complications, including heart attack, stroke and death from cardiovascular disease, according to research accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society.

One class of drugs, known as SGLT2 inhibitors, has a clear benefit over the other class, known as GLP-1 drugs, in reducing hospitalization for heart failure, the study found. “This helps doctors more easily choose a medicine to best treat diabetes,” said lead study author Ali Al-Khazaali, M.D., of Saint Louis University in St. Louis, Mo.

SUN-618: Decision Analysis for Glucagon-Like Peptide Receptor Agonists vs. Sodium-Glucose Cotransporter 2 Inhibitors in Type 2 Diabetes Mellitus

Background: Cardiovascular outcome trials (CVOT) of glucagon-like peptide-1 receptor agonists (GLP-1 RA) and sodium-glucose co-transporter 2 inhibitors (SGLT2i ) demonstrated reduction of major adverse cardiovascular events (MACE), cardiovascular deaths (CVD), and renal outcomes (RO). Objective. Evaluation of data to assist in the prescribing decision with regard to severity of illness and risk for adverse events.

Study Design: Systemic review of the major CVOT and previous meta-analyses.

Main Outcome Measures: Analysis of six trials on GLP-1 RA and 4 trials on SGLT2i, showed both drug classes reduced MACE and CVD compared to controls, with neither class preferred (comparison GLP1-RA vs SGLT2i: (relative rate, rr MACE= 1.09, 95%CI;0.98,1.22, p= 0.129; rr, CVD =1.04, CI;0.87,1.24, p=0.657). Hospitalization for heart failure (HHF) improved with SGLT2i (rr=0.68, CI; 0.61,0.76, p<0.001) but not with GLP-1 RA, (rr = 0.94, CI; 0.86,1.03, p=0.17). Both GLP-1 RA and SGLT2i showed significant reduction in RO (GLP-1RA, rr=0.83, CI; 0.75,0.912, p=<0.001, SGLT2i, rr=0.0.67, CI; 0.57,0.79, p=0.001) without a preferential difference between the classes ( GLP-1 RA vs SGLT2i, relative difference (rd) =0.005, CI;- 0.011,0.021, p=0.532, number needed to treat (NNT)=200). Serious adverse events (SAE) for SGLT2i were predominantly mycotic genital infections in women (number needed to harm (NNH) =13 and diabetic ketoacidosis NNH=595. Gastrointestinal intolerance was the major SAE in the GLP1-RA class (NNH=35).

Conclusion: Both GLP-1 RA and SGLT2i classes showed similar reduction in MACE, CVD, and RO. SGLT2i have advantages over GLP-1 RA in reduction in HHF especially in those with more severe cardiovascular disease risk.

 

[madman]

Study suggests marijuana may impair female fertility

Female eggs exposed to THC, the psychoactive ingredient in marijuana, have an impaired ability to produce viable embryos, and are significantly less likely to result in a viable pregnancy, according to an animal study accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting. The abstract will be published in the Journal of the Endocrine Society.

MON-010: Effects of Delta-9-Tetrahydrocannabinol (THC) on Oocyte Competence and Early Embryonic Development

 

[madman]

Artificial intelligence improves X-ray identification of patients with broken bones

Artificial intelligence that can “read” electronic radiology reports and flag patients with broken bones who are at risk of osteoporosis outperformed the traditional manual method of health care professionals reading X-ray reports, a new study finds. The results were accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and will be published in a special supplemental section of the Journal of the Endocrine Society.

The new search tool, called X-Ray Artificial Intelligence Tool (XRAIT), detected an almost fivefold higher number of major fractures, or bone breaks, in X-ray and computed tomography (CT) reports compared with manual methods, researchers from Australia reported.

OR29-02: Natural Language Processing of Radiology Reports Improves Identification of Patients with Fracture

Fracture liaison services (FLS) address the treatment gap for those with osteoporosis (OP) who fracture and are not treated. Given the limited human resources in FLS, screening high volumes of radiology reports for fractures with Natural Language Processing (NLP) could identify patients that have not been recognized or treated. This study is an analytical and clinical validation of X-Ray Artificial Intelligence Tool software (XRAIT) at its development site (a tertiary hospital) and external validation in an adjudicated cohort from the Dubbo Osteoporosis Epidemiology Study (DOES).

Methods: XRAIT uses NLP to perform a Boolean search of radiology reports for fracture and related terms. It can be trained for site-specific reporting styles and use rules to refine identification (e.g. age>50y; bone involved; etc). At the development site, XRAIT was used to search the emergency patient presentations of people over 50 years of age and compared to referrals to FLS (usual care) during the same 3-month period. XRAIT analyzed all plain radiographs and CT scans (n = 5089) while n = 224 were referred to FLS for usual care. External validation: XRAIT was used to analyze digitally readable radiology reports in an untrained cohort from DOES (n = 327) to calculate sensitivity and specificity.

Results: XRAIT identified a 5-fold higher number of potential significant fractures (349/5089) compared to manual case finding (70/224). 339/349 were confirmed fractures (97.1%). Only 29% of those eligible were started or recommended anti-resorptive therapy, including those seen by the fracture liaison service. XRAIT unadjusted for the local radiology reporting styles in DOES had a sensitivity of 69.6% and specificity of 95%.

Conclusion: XRAIT identifies clinically significant fractures efficiently with minimal additional human resources. Its high specificity in an untrained cohort suggests it could be used at other sites. Automated methods of patient identification may assist fracture liaison services to identify fractures that still remain largely untreated.

 

[madman]

Pregnant women’s PFAS exposure linked to granddaughters’ obesity risk

The first human study to link blood levels of “forever” chemicals known as PFAS in pregnant women with the risk of obesity in their granddaughters is described in an ENDO 2020 abstract that will be published in the Journal of the Endocrine Society.

Per- and polyfluoroalkyl substances (PFAS) are man made chemicals used as oil and water repellents and coatings for common products including cookware, carpets and textiles. These endocrine-disrupting chemicals persist when they are released into the environment, and they continue to accumulate over time.

SAT-LB132: 3-Generation Study of Metabolic Disruption by Pregnancy Serum PFASs: Associations with Abdominal and Whole-Body Obesity in Granddaughters in a 60-Year Follow-Up of the Child Health and Development Studies Cohort

Introduction: We previously found a 3.6-fold increased risk of breast cancer in daughters associated with high maternal (F0) early postpartum serum EtFOSAA combined with high F0 cholesterol (Redirecting). Here we test the hypothesis that F0 early postpartum EtFOSAA, in combination with F0 serum cholesterol predicts abdominal obesity (waist circumference > 88cm) and/or whole-body obesity (body mass index > 30 kg/m2) in daughters (F1) at age 30 and granddaughters (F2) at age 20.

Methods: We measured F1 and F2 weight, height, waist circumference and blood pressure when F1 were an average age of 50 years and adult F2 were an average age of 20 years (N=219 dyads). F1 also reported their weight at age 30, near the mean age of their pregnancies with their daughters (F2) to allow control for obesity during F2 gestation. EtFOSAA, PFOS, and cholesterol were assayed in archived early postpartum F0 serum samples collected within 3 days of delivery.

Results: F0 cholesterol significantly (p<0.05) modified the association of F0 EtFOSAA with self-reported obesity at age 30 in F1 and measured abdominal and whole-body obesity, and blood pressure at age 20 in F2. Association patterns were similar for all outcomes: F0 EtFOSAA was associated with high metabolic risk when F0 serum cholesterol was low (Quartile 1): e.g. 20-year-old F2 had an estimated 2.3 fold increase in the joint risk of abdominal and whole-body obesity over the inter-quartile range of F0 ETFOSAA , 95% Confidence Interval= 1.1, 4.8. F0 EtFOSAA associations with F2 metabolic risk were independent of F0 race, early pregnancy overweight (BMI >25 kg/m2), and serum PFOS. F1 obesity at age 30 did not mediate F0 EtFOSAA associations with F2 outcomes, but additionally predicted high metabolic F2 risk.

Conclusions: Findings support the hypothesis that in utero exposure to EtFOSAA impacts metabolic risk factors in female F2 exposed as germline and also independently via promotion of overweight in F1 (their mothers) during F2 gestation.

 

[madman]

Chemicals used to replace BPA may lead to increased blood pressure

Common bisphenol A (BPA) substitutes can affect the developing fetus and cause hypertension in later life, suggests a rodent study accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting. The research will be published in a special supplemental section of the Journal of the Endocrine Society.

SAT-719: Prenatal Exposure to Bisphenol A, S and F Increases Blood Pressure in Female Rats

Night-time systolic BP was significantly elevated in BPA, BPF and BPS exposed rats compared to control. During the day, systolic BP was significantly higher in the BPA group compared to control. Diastolic BP was elevated in the BPS and BPF groups. Heart rate was elevated the most in the BPS group. These results indicate that prenatal exposure to low levels of BPA analogs has a profound effect on hypertension.

 

[madman]

Medtronic MiniMed 670G insulin pump allows “excellent” blood glucose control

Patients with type 1 diabetes who use Medtronic’s MiniMedTM 670G insulin pump system are able to maintain blood glucose levels in the targeted range over 71% of the time, according to a study that analyzed some 6 million days of real-world data. Results of the industry-supported study were accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and will be published in a special supplemental issue of the Journal of the Endocrine Society.

OR30-01: Real-World Minimed™ 670G System Use and Glycemic Outcomes of Pediatric and Adult Individuals Living with Type 1 Diabetes (T1D) in the United States

Introduction: The MiniMed™ 670G system was FDA-approved in 2016 for adults and adolescents ≥14yrs, and in 2018 for children ages 7-13yrs with T1D. Since then, use of the system has grown to over 180,000 people in the U.S. The glycemic control benefits of real-world MiniMed™ 670G system Auto Mode use in the U.S. were assessed.

Methods: System data (aggregated five-minute instances of sensor glucose [SG]) uploaded from March 2017 to July 2019 by individuals (N=118,737) with T1D and ≥7yrs of age who enabled Auto Mode were analyzed to determine the mean % of overall time spent <54 mg/dL/<70 mg/dL (TBR); between 70- 180 mg/dL (TIR); and >180 mg/dL/>250 mg/dL (TAR). The impact of Auto Mode was further assessed in a sub-group of individuals (N=51,254) with, at least, 7 days of SG data for both Auto Mode turned ON and turned OFF. The % of TIR, TBR and TAR, and the associated glucose management indicator (GMI) were evaluated for the overall OFF (2,524,570 days) and ON (6,308,806 days) periods, and across different age groups.

Results: System data TIR was 71.3%; TBR was 0.4% and 1.9%, respectively; and TAR was 26.8% and 6.2%, respectively. User-wise data of Auto Mode OFF versus ON showed a mean of 70.3% of the time spent in Auto Mode, that TIR increased from 60.9% to 69.9%; and that both TBR and TAR decreased. For those 7- 13yrs (N=1,417), TIR increased from 48.7% to 61.5%; TBR increased from 0.5% to 0.6% and from 2.0% to 2.2%, respectively; and TAR decreased from 49.3% to 36.3% and from 20.5% to 13.0%, respectively. For those 14-21yrs (N=4,194), TIR increased from 51.0% to 61.5%; TBR decreased from 0.7% to 0.6% and from 2.3% to 2.0%, respectively; and TAR decreased from 46.7% to 36.5% and from 18.5% to 12.5%, respectively. For those ≥22yrs (N=45,643), TIR increased from 62.2% to 70.9%; TBR decreased from 0.7% to 0.5% and from 2.6% to 1.9%, respectively; and TAR decreased from 35.2% to 27.3% and from 9.9% to 6.3%, respectively. The mean GMI decreased by 0.23% (overall), 0.48% (7-13 yrs), 0.35% (14-21yrs), and 0.22% (≥22yrs), respectively, with Auto Mode ON versus OFF.

Discussion: In over 6 million days of real-world MiniMed™ 670G system Auto Mode use in the U.S., TIR of a large pediatric and adult population with T1D improved by 9% compared to when Auto Mode was OFF, which was comparable to or exceeded the TIR observed in the smaller pivotal trials. These results further support outcomes of the pivotal trials and increased glycemic control with system use.

 

[madman]

Loss of gland in eyelids may be a biomarker for elevated blood glucose in diabetes

In patients with diabetes, loss of the gland that helps lubricate the eye may be a sign of elevated blood glucose levels, according to research accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting. The study will be published in a special supplemental section of the Journal of the Endocrine Society.

Meibomian glands in the eyelid play a role in tear film production and tear film stabilization.

MON-704: Tear Glands and the Diabetic Patient: Is It a Biomarker?

Background: Tear glands in the eyelids, meibomian glands, play a role in tear film production and tear film stabilization. Diabetic patients often complain of dry eye and eye pain. Recently, there are new infrared (820nm) photography techniques to image meibomian glands easily in patients.

Purpose: To study meibomian glands in diabetic patients with dry eye.

Methods: A retrospective chart review (2017-2019) of Type 2 Diabetes Mellitus (T2DM) patients and non-diabetic patients with the diagnosis of "dry eye" in EHR (eClinicalworks, Westborough, MA ) was performed. Infrared eyelid imaging (820 nm wavelength, Heidelberg Spectralis, Heidelberg, Germany) was taken. T2DM: Inclusion criteria: 1) HbA1c of > 5.7% who also had infrared eyelid imaging performed + 4 weeks of their HbA1c lab test results; 2) the percentage loss of meibomian glands for each eye, then averaged, for each patient. Control: Inclusion criteria: 1) non-diabetic patients; 2) HbA1c lab test results; 3) infrared eyelid imaging was performed; 4) percentage loss of meibomian glands was calculated for each eye, then averaged per patient. Exclusion criteria for both T2DM and Controls: younger than the age of 18 years old, older than 90 years old, no glaucoma topical medications, no eyelid surgery, no corneal surgery, no conjunctival surgery.

Results: n=120 patients, Avg Age=69.6 years (sd=15.1, range 23-89 years). Diabetic patients: n=60 patients, Male=30, Female=30, Avg Age=65.1 years (sd=11.50, med=65.5, range 36-85 years). Controls: n=60 patients, Male=37, Female=23, Avg Age=54.1 years (sd=16.4, med=56.5, range 23-89 years). Meibomian gland loss: Diabetics=51.54%, Controls=11.29% (p<0.0001, t-test). Of the 60 DM patients: 35/37 pts with HbA1c > 6.6% had greater loss of meibomian glands (>40%), compared to 12/23 DM patients with HbA1c < 6.5%, p=0.0001.

Discussion: Loss of meibomian glands in diabetic patients have been recently investigated; however, its relationship to HbA1c as a possible biomarker has not been widely discussed in literature. In this small study, loss of meibomian glands occur more frequently with elevated HbA1c, perhaps due to microischemia of the eyelids, thereby resulting in loss of meibomian glands.

Conclusion: Loss of meibomian glands may suggest a need for HbA1c testing and further monitoring of the patient's diabetic condition. Infrared imaging of the eyelid may be useful in characterizing dry eye in diabetic patients.

 

[madman]

Bariatric surgery before diabetes develops leads to greater weight loss

Obese patients may lose more weight if they undergo bariatric surgery before they develop diabetes, suggests a study accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting.The research will be published in a special supplemental issue of the Journal of the Endocrine Society.

MON-590: Presence of Diabetes Diminishes the Ultimate Weight Loss After Bariatric Surgery

Background: Obesity and diabetes as well as their related complications result in both individual and global health burdens. Among patients who present with both obesity and diabetes, bariatric surgery can lead to remission of both these diseases. However, the possible impact of diabetes on the magnitude of weight loss outcomes after bariatric surgery has not been quantified.

Methods: To address this question, we extracted data from Michigan Bariatric Surgery Cohort (MI-BASiC) to see whether diabetes at baseline could be a predictor of weight loss outcomes. Consecutive patients 18 years of age or older undergoing gastric bypass (GB) or sleeve gastrectomy (SG) for obesity at the University of Michigan between January 2008 and November 2013 were included in our retrospective cohort. All patients had either body mass index (BMI) > 40 kg/m2 or BMI 35 – 39.9 kg/m2 with comorbid condition. Firstly, we performed Generalized Linear Mixed Model (GLMM) analysis to compare the probability of achieving BMI under 30kg/m2 or achieving excess body weight loss (EBWL) 50% or more for patients with or without diabetes. We then further tested the effect of presence of diabetes for the BMI outcomes across time using Linear Mixed Model (LMM) analysis. Finally, we conducted a LMM analysis to determine if diabetes is a predictor of the future weight loss, percentage of total weight loss or percentage of excess weight loss over 5 years of follow up.

Results: Based on our criteria, 380 patients were included for GB [female 305 (80.3%), mean age 43.6±0.6 years, mean BMI 47.3±0.4kg/m2, diabetes 149 (39.2%), on insulin 45 (11.8%)] and 334 for SG [female 259 (77.5%), mean age 45.3±0.6 years, mean BMI 49.9±0.5kg/m2, diabetes 108 (32.3%), on insulin 29(8.7%)]. From GLMM analysis, the presence of diabetes at baseline did not impact the probability of achieving BMI under 30 kg/m2 (p=0.0848), but substantially impacted the probability of achieving 50% or more EBWL (p=0.0021) with individuals without diabetes having a 1.6 (odds ratio 1.56, 95% CL [1.18-2.08]) times higher chance to achieve this threshold. We also showed that individuals with diabetes at baseline had a significant effect to modify BMI points lost, regardless of the surgery type (p=0.0178). The presence of diabetes at baseline diminished weight loss by 1.2 BMI points (95% CL [0.21- 2.20]) which is roughly 10 to 15% of the total BMI points to be lost. LMM analysis further confirmed that after adjusting the time, surgery type, age, gender and baseline weight, there was still a significant difference of absolute weight loss (p=0.0110), percentage of total weight loss (p=0.0089) and percentage of excess weight loss (p=0.0365) between individuals with diabetes versus individuals without diabetes.

Conclusion: In conclusion, our data demonstrate that diabetes diminishes the ultimate weight loss effect of bariatric surgery. Further research is needed to understand why this is the case.

 

[madman]

Better controlled diabetes is associated with preserved cognitive function following stroke

Better glucose control can help people with diabetes who have a common type of stroke to preserve their cognitive function, according to a study accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting. The abstract will be published in a special supplemental issue of the Journal of the Endocrine Society.

MON-636: The Relationship Between Glucose Control & Cognitive Function in People with Diabetes After a Lacunar Stroke

Background & Objective: Both lacunar strokes and diabetes are risk factors for dementia and cognitive dysfunction. Thus, elucidating modifiable risk factors for cognitive dysfunction in people with type 2 diabetes who experienced a lacunar infarct has large public health implications. One such factor may be glycemic status, as measured by glycosylated hemoglobin (A1C). Thus, the aim of this study was to assess the relationship between A1C and cognitive function in people with diabetes after a lacunar stroke. Research Design &

Methods: The effect of baseline and follow-up A1C on the baseline and the change in Cognitive Assessment Screening Instrument (CASI) score over time among participants with a median of 2 cognitive assessments (range 1-5) was examined in of 942 individuals with diabetes and a lacunar stroke who participated in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial (ClinicalTrials.gov number, NCT00059306).

Results: Every 1 % higher baseline A1C was associated with a 0.06 lower standardized CASI z-score (95% CI -0.101, -0.018). Higher baseline A1C values were associated with lower CASI z-score over time (p for interaction=0.037). A 1% increase in A1C over time, corresponded with a CASI score decrease of 0.021 (95% CI -0.0043, -0.038) during follow-up. All these remained statistically significant after adjustment for age, sex, education, race, depression, hypertension, hyperlipidemia, BMI, CVD, OSA, diabetic retinopathy, nephropathy insulin use and White Matter Abnormalities.

Conclusion: This analysis of 942 individuals with diabetes after a lacunar stroke demonstrates a relationship between A1C and change in cognitive scores over time. Intervention studies are needed in order to delineate if better glucose control could slow the rate of cognitive decline in this high risk population.

 

[madman]

Non-drug therapy ‘Revita’ improves blood glucose levels, liver metabolic health in patients with type 2 diabetes

Patients with poorly controlled type 2 diabetes who underwent a novel, minimally invasive, endoscopic procedure called Revita® duodenal mucosal resurfacing (DMR) had significantly improved blood glucose (sugar) levels, liver insulin sensitivity, and other metabolic measures three months later, according to new data from the REVITA-2 study. These results, from a mixed meal tolerance test, have helped researchers verify the insulin sensitizing mechanism by which hydrothermal ablation of the duodenum improves blood sugar in patients with type 2 diabetes.

The research was accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and will be published in a special supplemental section of the Journal of the Endocrine Society.

OR30-07: Mixed Meal Tolerance Test (MMTT) Results from Revita-2, the First Randomized, Sham-Controlled, Double-Blind, Prospective, Multicenter Study of Duodenal Mucosal Resurfacing (DMR) Safety and Efficacy in Patients with Sub-Optimally Controlled Type 2 Diabetes (T2D)

Background: The duodenum is a key metabolic signaling center and regulator of metabolic homeostasis. Duodenal mucosal hyperplasia is therefore a potential therapeutic target for metabolic diseases related to insulin-resistance. Previous reports demonstrated that DMR, a minimally invasive, endoscopic mucosal ablative procedure, safely improves hepatic and glycemic parameters. Primary endpoints from REVITA-2, the first randomized, sham controlled, double-blind, prospective, multicenter study of DMR safety and efficacy in patients with T2D, were met and previously reported. Here we further explore mechanisms underlying the beneficial effects of DMR on hepatic and glucose metabolism by analyzing mixed meal tolerance test (MMTT) data from the REVITA-2 study.

Methods: Eligible patients (HbA1c 7.5-10%, BMI ≥ 24 to ≤ 40 kg/m2, on stable treatment with ≥1 oral anti-diabetic medication) received DMR or sham procedure (1:1). Exploratory endpoints included median change in fasting plasma glucose (FPG), MMTT glucose area under the curve (AUC) over 2 hours, and change in MMTT C-peptide and glucagon over 2 hours, from baseline to 12 weeks post-DMR. One-sided P value based on ANCOVA model on ranks without imputation assessed treatment difference at the 0.05 significance level. The modified intent to treat primary analysis population included randomized patients in whom study procedure was attempted.

Results: A total of 70 patients (DMR, N = 35; sham, N = 35) were included in the analysis, of which 57% and 54% (DMR, n = 20; sham, n = 19) had baseline FPG ≥ 180 mg/dL. Median MMTT AUC for glucose was significantly reduced post-DMR (-36.38 mg/dL) compared with sham (-4.94 mg/dL; P = 0.009), driven by a significant decrease in FPG (DMR, -41.0 mg/dL; sham, -15.0 mg/dL; P = 0.003) rather than median MMTT postprandial glucose excursion (DMR, -4.63 mg/dL; sham, 5.34 mg/dL; P = 0.209). AUC glucose reductions were more pronounced in patients with baseline FPG ≥ 180 (DMR, -63.03 mg/dL; sham, -20.31 mg/dL; P = 0.007) compared with baseline FPG < 180 (DMR, -26.81 mg/dL; sham, 13.81 mg/dL; P = 0.271). In patients with baseline FPG ≥ 180, postprandial C peptide excursion was significantly increased (DMR, 0.41 ng/mL; sham, 0.02 ng/mL; P = 0.012) and postprandial glucagon excursion was significantly decreased (DMR, -8.03 pg/mL; sham, 2.13 pg/mL; P = 0.027).

Conclusion: DMR markedly improves glucose responses to a mixed meal challenge, primarily driven by a decrease in FPG, suggesting a primary effect on insulin resistance. Increases in C-peptide and reductions in glucagon levels suggest improvement in beta cell function in addition to improvements in hepatic insulin sensitivity, and ratifies the position of the duodenum as both a culprit endocrine organ and therapeutic target for patients with T2D.

 

[madman]

Diabetes care reaches new heights as drone delivers insulin for patient

The international medical team that accomplished the world’s first documented drone delivery of insulin for a patient living in a remote community described the project in an ENDO 2020 abstract that will be published in the Journal of the Endocrine Society.

OR30-04: Autonomous Drone Delivery of Insulin

We had our maiden flight on September 13, 2019 from Galway, Ireland to the Aran Islands (20 Km each way) delivering insulin from the pharmacist to the patient’s clinician. This represents the first documented autonomous delivery of insulin for a patient with diabetes.