Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT06730113
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 25 Years
Healthy Volunteers
Accepted

Study Details

Background: Type 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people. Objective: To learn more about factors, including type 2 diabetes, that may cause vascular disease in young people. Eligibility: People aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed. Design: Young participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days. At each visit, participants will have tests including: Samples: They will provide blood, urine, and stool samples. Heart: They will ride a stationary bike for 6 minutes with stickers applied to their chest. Scans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body. Energy: They will wear a hood over their head to measure the air they breathe. Social stress: They will give a speech for 10 minutes to show their body s response to stress. Glucose: They will drink a sweet drink to see how their blood sugar changes. Biological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress. ...

Key Dates

Start date
Mar 12, 2025
Status verified
May 2026
Primary completion
Oct 31, 2033
Completion
Oct 31, 2033

Study Design

Enrollment
930 participants (estimated)

Arms

  • Arm: Healthy control lean participants (Y-Lean)
    A prospective, observational study design in youth aged 12-25 years to compare Y-T2DM with age and BMI-matched youth with overweight or obesity (Y-OW) and age-matched healthy lean peers (Y-Lean).
  • Arm: Y-T2DM
    A prospective, observational study design in youth aged 12-25 years to compare Y-T2DM with age and BMI-matched youth with overweight or obesity (Y-OW) and age-matched healthy lean peers (Y-Lean).
  • Arm: Youth with overweight/ obesity (Y-OW
    A prospective, observational study design in youth aged 12-25 years to compare Y-T2DM with age and BMI-matched youth with overweight or obesity (Y-OW) and age-matched healthy lean peers (Y-Lean).

Primary Outcome Measure

Pulse wave velocity (PWV) [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National Hospital (CNH)Washington D.C.District of Columbia20010
Doris Estrada
[email protected]
202-476-2121
National Institutes of Health Clinical CenterBethesdaMaryland20892
Stephanie Chung, M.D.
[email protected]
240-479-8137

Find similar trials in Washington D.C., DC

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's National Hospital (CNH)· Washington D.C., DCNational Institutes of Health Clinical Center· Bethesda, MD

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