Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: f
View:

• 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)

Locations
United States
Connecticut
Yale Pediatric Diabetes Research
RECRUITING
New Haven
Contact Information
Primary
Rehema Mtawali
rehema.mtawali@yale.edu
(475) 414-4035
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2028-06
Participants
Target number of participants: 15
Treatments
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.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Yale University

This content was sourced from clinicaltrials.gov