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.

...

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