NCT06105931
Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
Active, Not Recruiting
PHASE1Ages 18–30InterventionalBasic scienceYale UniversityInvestigator-initiated
~15 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Hyperinsulinemic-euglycemic clampHigh Fat Mixed Meal Tolerance Test
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in VAT/(VAT+SAT) from baseline to 1 year
Measured over baseline and 1 year
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesConnecticut1
Study leadership
- Michelle Van Name, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
Exclusion
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
What this trial measures
- Change in VAT/(VAT+SAT) from baseline to 1 yearbaseline and 1 year
Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year in young adults with T1D and body mass index \<25kg/m2.
- Change in hepatic insulin resistance from baseline to 1 yearbaseline and 1 year
Hepatic insulin resistance, measured by beta-hydroxybutyrate (surrogate marker of acetyl-CoA, which regulates gluconeogenesis), changes over 1 year in young adults with T1D and body mass index \<25kg/m2.
- Change in triglycerides from baseline to 1 yearbaseline and 1 year
Change in triglycerides after a high-fat mixed meal tolerance test, expressed as the total Area Under the Curve (AUCTG) over 6 hours from baseline to 1 year.