Understanding cardiometabolic risk in young adults with type 1 diabetes
Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
This study is trying to understand the heart and metabolic health risks in young adults with type 1 diabetes who are at a normal weight to help improve future treatments for those with diabetes and obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06105931 on ClinicalTrials.gov |
What this trial studies
This study investigates the physiological markers of cardiometabolic risk in young adults with type 1 diabetes who have a normal body mass index. It aims to collect reference data over one year to assess changes in visceral adipose tissue, hepatic insulin resistance, and postprandial lipemia. The study employs interventions such as hyperinsulinemic-euglycemic clamps and high-fat mixed meal tolerance tests to gather comprehensive data. The findings will inform future trials on GLP-1 analogue obesity treatments for those with type 1 diabetes and obesity.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18 to 30 with type 1 diabetes and a body mass index less than 25 kg/m2.
Not a fit: Patients currently using adjunctive diabetes or anti-obesity medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiometabolic risks in young adults with type 1 diabetes.
How similar studies have performed: While similar studies have explored cardiometabolic risks in diabetes, this specific approach focusing on young adults with normal BMI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 to ≤30 years * Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2. * HbA1c ≤10% * Clinical use of continuous glucose monitoring (CGM) * Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year: 1. Baseline creatinine \>1.0mg 2. Hypertriglyceridemia (\>400 mg/dl) 3. ALT ≥3.5 times the upper normal limit (UNL) Exclusion Criteria: * Current use of adjunctive diabetes medication or anti-obesity medication * Insulin dose \<0.5 units/kg/day * Use of lipid lowering prescription medication other than statins or omega-3 products * Doesn't meet MRI safety criteria or having claustrophobia * Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease * Known renal impairment * Pregnancy or lactation, or planning to become pregnant during the study period. * Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation. * Treatment with another investigational drug within the past 1 month * Past medical history of or self-reported corn allergy
Where this trial is running
New Haven, Connecticut
- Yale Pediatric Diabetes Research — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Van Name, MD — Yale University
- Study coordinator: Rehema Mtawali
- Email: rehema.mtawali@yale.edu
- Phone: (475) 414-4035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.