Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study (NCT06730113) | Clinical Trial Compass
RecruitingNot Applicable
Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study
United States930 participantsStarted 2025-03-12
Plain-language summary
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.
...
Who can participate
Age range
12 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with Y-T2DM
Exclusion criteria
. 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.
No Exclusion Criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically about youth-onset Type 2 diabetes and heart disease risk — does my child's age at diagnosis and current health profile match what this study is looking for?
2The trial is measuring pulse wave velocity and augmentation index, which are tests of artery stiffness — are these tests something my child would need to do repeatedly, and how demanding or invasive are they?
3Since this is listed as a cohort study with no assigned phase, it sounds like it's observational rather than testing a treatment — does that mean my child wouldn't receive any experimental medication, and what would actually be expected of us if we participated?
4Given that this is a prospective cohort study tracking heart disease risk over time, how long would my child need to stay enrolled, and what would that commitment look like in terms of clinic visits or follow-up appointments?
5Are there standard care options or existing programs for managing youth-onset Type 2 diabetes and reducing cardiovascular risk that we should be pursuing alongside or instead of joining this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulse wave velocity (PWV)
Timeframe: Baseline
2
Augmentation index (Aix)
Timeframe: Baseline
3
Pulse wave velocity (PWV)
Timeframe: 5 Years
4
Augmentation index (Aix)
Timeframe: 5 Years
Trial details
NCT IDNCT06730113
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)