RecruitingPhase 2NCT06411210

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

Sponsor

Yale University

Enrollment

54 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Diabetes type1

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 30 Years

Inclusion Criteria14

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
Creatinine \<1.0mg
Triglycerides (\<400 mg/dl)
ALT \<3.5 times the upper normal limit (UNL)

Exclusion Criteria18

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