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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-25
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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.

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Eligibility criteria

Qualifiers

Participants with Y-T2DM

Disqualifiers

b. Medical, psychiatric or cognitive disorders that will, in the opinion of the investigators, limit the subject s ability to comply with study procedures (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis).

h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

930 Participants
are grouped into 3 trial groups

Locations

2
Children's National Hospital (CNH)20010, Washington D.C.District of Columbia, United States
National Institutes of Health Clinical Center20892, BethesdaMaryland, United States

Sponsors and collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead sponsor