Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Obesity Complicating Type 1 Diabetes in Young Adults: Physiology and Impact of GLP-1 Analogue Anti-obesity Treatment on Cardiometabolic Risk Factors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 30 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 52 weeks, 4 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "After completing these baseline measures, participants will be randomized in a 2:1 ratio to receive weekly injected semaglutide (escalated to 2.4 mg or maximum tolerated dose) or placebo to treat obesity for 52 weeks."
- "They will then complete a wean off of study drug (up to 4 weeks) and 2 weeks of additional monitoring for insulin titration."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how GLP-1 weight-loss medicine affects signs of heart and blood sugar health. It is for adults ages 18–30 with type 1 diabetes and obesity, or overweight with a weight-related health problem.
More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes, however evaluation of these agents in people with T1D has been limited to glycemic outcomes. Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–30 years old and were diagnosed with type 1 diabetes at least 12 months ago.
- Your BMI, a measure of weight compared with height, is at least 30, or at least 27 with a weight-related health problem.
- Your HbA1c, a measure of average blood sugar, is 10% or less at screening and within the past 90 days.
- In the past 90 days, your insulin dose has changed by no more than 15%, and your BMI by no more than 5%.
- You use a real-time continuous glucose monitor to track blood sugar and plan to keep using it.
- You can give written consent and agree to follow study visits, tests, and medicine instructions for the whole study.
- If you could become pregnant or cause a pregnancy, you agree to use a highly effective birth control method starting at least 1 month before study group assignment, throughout the study, and for 2 months after the last dose. Complete avoidance of male-female sex also qualifies.
- Your screening blood tests meet these limits: creatinine, a kidney test, below 1.0 mg; triglycerides, a blood fat, below 400 mg/dL; and ALT, a liver test, below 3.5 times the upper normal limit.
Who can't join
- You used diabetes medicines besides insulin or weight-loss medicines in the past 6 months; use less than 0.5 units of insulin per kilogram of body weight per day; or take cholesterol-lowering medicines other than statins or omega-3 products.
- You have had pancreatitis (swelling of the pancreas), kidney problems, or liver disease other than non-alcoholic fatty liver. You or a family member has had medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2, a condition that can cause tumors in hormone-making glands.
- You have a known or suspected allergy to semaglutide, its ingredients, or related products; a corn allergy; or serious gastroparesis, which slows stomach emptying.
- You have a mental health condition that affects weight, including an eating disorder; a PHQ-9 depression score above 15; any past suicide attempt; or suicidal thoughts in the past 3 months.
- You are pregnant, breastfeeding, planning to become pregnant, or not using adequate birth control.
- You had diabetic ketoacidosis, a dangerous buildup of acids in the blood, in the past 6 months, or very low blood sugar that required a hospital stay in the past 3 months.
- You cannot safely have an MRI scan or fear enclosed spaces enough to prevent the scan. You have anemia (low red blood cells), a blood condition that affects HbA1c results, or another health condition that prevents participation.
- You were already assigned to a treatment group in this trial, or received another experimental drug or treatment in the past month. People who enrolled but were not assigned to a group may be screened again.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity) * Clinical diagnosis of T1D * Diabetes duration diagnosed ≥ 12 months ago * HbA1c ≤10% at screening and within the past 90 days * Stable reported insulin dosing in the past 90 days (within 15%) * Stable reported BMI in the past 90 days (within 5%) * Ability to provide written informed consent before any trial-related activities * Use of real-time continuous glucose monitoring and planned continued use * Females and males of childbearing potential willing to use highly effective methods of contraception for at least 1 month prior to randomization and agreement to use such a method during study participation and for 2 months after the last dose of study medication administration: Combined estrogen-progestogen contraception including: oral, intravaginal, transdermal (patch), Progestogen-only contraception: oral, injectable or implantable, Placement of an intrauterine device or intrauterine system, Bilateral tubal occlusion (fallopian tubes are blocked), Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), or Complete sexual abstinence from male-female sex) * Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study * Participants cannot be randomized if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have 1. Creatinine \<1.0mg 2. Triglycerides (\<400 mg/dl) 3. ALT \<3.5 times the upper normal limit (UNL) Exclusion Criteria: * Use of adjunctive diabetes therapies or anti-obesity medications (including any GLP-1 agonist) currently or within the past 6 months. * Insulin dosing \<0.5 units/kg/day * Current psychiatric conditions impacting weight, including known eating disorders * Contraindications to study medications, including: * Personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis * Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2 * Known or suspected allergy to semaglutide, excipients, or related products. * Use of lipid lowering medications other than statins and omega-3 products * Previous randomization in this trial. Participants who enrolled but did not randomize can be re-screened. Potential reasons for enrolment without randomization include scheduling conflicts for the baseline studies, or for females, not yet meeting the highly effective methods of contraception criteria. * Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures * Diabetic ketoacidosis in the past 6 months * Not meeting MRI safety criteria or claustrophobia preventing participation in the MRI * Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation. * Treatment with another investigational drug or other intervention within the past 1 month * Subjects with a PHQ-9 score \>15 or those found to have a lifetime history of suicide attempts, or suicidal ideation within the past 3 months on the C-SSRS * Corn allergy * Subjects with severe hypoglycemia requiring hospitalization in the past 3 months * Clinically significant gastroparesis
Study sites (1)
CT
- Yale Pediatric Diabetes Center, Adult and Children's Progam · New Haven, CT 06520More trials in New Haven