Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-30
SponsorYale University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hyperinsulinemic-euglycemic clamp
Biological/VaccineHyperinsulinemic-euglycemic clamp will be used to assess insulin resistance. After IVs are placed, participants will be transitioned to intravenous insulin administration for the baseline portion of the study. Stable Isotope Tracer Infusions will assess rates of glucose, lipid metabolism, and beta-hydroxybutyrate turnover during the last 30 minutes of the baseline equilibration period and again during the last 30 minutes of the stepped IV insulin infusion periods.
High Fat Mixed Meal Tolerance Test
Other interventionAfter a 12 hour overnight fast, baseline levels of the lipoproteins will be drawn. The YCCI Bionutrition Service kitchen will prepare the standardized high-fat meal. Participants will administer their bolus insulin per their home regimen for the carbohydrates in the high-fat meal, and then they will consume the meal within a 15-minute timeframe.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Young adults with T1D who have a body mass index <25 kg/m2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in VAT/(VAT+SAT) from baseline to 1 year
Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year in young adults with T1D and body mass index \<25kg/m2.
Time frame
baseline and 1 year2
Change in hepatic insulin resistance from baseline to 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.
Time frame
baseline and 1 year3
Change in triglycerides from baseline to 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.
Time frame
baseline and 1 yearSponsors and contacts
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Yale University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov