Status:
RECRUITING
Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
type1diabetes
Obesity
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
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 refere...
Detailed Description
Primary Objective The primary objectives of this physiologic study are to: 1. examine how visceral adipose tissue (VAT), measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year in youn...
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:
- Baseline creatinine \>1.0mg
- Hypertriglyceridemia (\>400 mg/dl)
- ALT ≥3.5 times the upper normal limit (UNL)
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
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06105931
Start Date
December 13 2023
End Date
June 1 2028
Last Update
May 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale Pediatric Diabetes Research
New Haven, Connecticut, United States, 06520