NCT06105931 Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
| NCT ID | NCT06105931 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | type1diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2023-12-13 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Michelle Van Name, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06105931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06105931 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06105931 currently recruiting?
Yes, NCT06105931 is actively recruiting participants. Contact the research team at rehema.mtawali@yale.edu for enrollment information.
Where is the NCT06105931 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06105931 clinical trial?
NCT06105931 is sponsored by Yale University. The principal investigator is Michelle Van Name, MD at Yale University. The trial plans to enroll 15 participants.
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