Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06105931
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperinsulinemic-euglycemic clamp — BIOLOGICAL
    Hyperinsulinemic-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
    After 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.

Study Details

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.

Key Dates

Start date
Dec 13, 2023
Status verified
Apr 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Young adults with T1D who have a body mass index <25 kg/m2
    Young adults with T1D who have a body mass index \<25 kg/m2 will have: abdominal MRI, hyperinsulinemic-euglycemic clamp wtih stable isotope tracer, DEXA scan and a High Fat Mixed Meal Tolerance Test.

Primary Outcome Measure

Change in VAT/(VAT+SAT) from baseline to 1 year [ Time Frame: baseline and 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Pediatric Diabetes ResearchNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Yale Pediatric Diabetes Research· New Haven, CT

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