NCT06105931Active, not recruitingPhase 1
Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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. Investigators aim to obtain reference data for individuals with T1D who do not have overweight obesity, to understand how close GLP-1 analogue obesity treatment in those with overweight/obesity brings physiologic markers of cardiometabolic risk to those with BMI in the normal range. Specifically, investigators will describe how drivers of gluconeogenesis and lipemia (specifically measured as visceral fat ratio, insulin resistance, and postprandial lipemia,) that contribute to cardiometabolic risk in T1D change over time.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 23 Oct 2023
- Start date
- 13 Dec 2023
- Primary completion date
- Aug 2027
- Lead sponsor
- Yale University
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT06105931
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 15
- From 13 Dec 2023 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of lipid lowering prescription medication other than statins or omega-3 products
- Treatment with another investigational drug within the past 1 month
Other illness
- Current use of adjunctive diabetes medication or anti-obesity medication
- Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease
- Known renal impairment
- Past medical history of or self-reported corn allergy
Lab values
- Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.
Other
- Insulin dose \<0.5 units/kg/day
- Doesn't meet MRI safety criteria or having claustrophobia
- Pregnancy or lactation, or planning to become pregnant during the study period.
Who the study is looking for
- 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:
- Baseline creatinine \>1.0mg
- Hypertriglyceridemia (\>400 mg/dl)
- ALT ≥3.5 times the upper normal limit (UNL)
Age in the registry: 18 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale Pediatric Diabetes Research Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.