RECRUITING

Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Obesity Complicating Type 1 Diabetes in Young Adults: Physiology and Impact of GLP-1 Analogue Anti-obesity Treatment on Cardiometabolic Risk Factors

Quick Facts

Study Start:2024-07-16

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06411210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Rehema Mtawali

CONTACT

203-785-7455

rehema.mtawali@yale.edu

Principal Investigator

Michelle Van Name, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale Pediatric Diabetes Center, Adult and Children's Progam

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Michelle Van Name, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-07-16

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

Diabetes type1
Obesity