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

This trial accepts healthy volunteers

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 population

This study will evaluate the pathophysiological features of cardiovascular disease in youth-onset type 2 diabetes (Y-T2DM) using a multi-level, multi-domain approach of socio-ecological risk factors (societal, community, and individual). We will employ 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). The study will also include a single-day visit for biological parents of enrolled Y-T2DM, Y-OW and Y- lean, to assess parental factors involved in the pathophysiology of cardiovascular disease in Y-T2DM.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

930 Participants
are grouped into 3 trial groups
Group A: Healthy control lean participants (Y-Lean)
Group B: Y-T2DM
Group C: Youth with overweight/ obesity (Y-OW

Trial outcomes

Primary outcomes

1

Pulse wave velocity (PWV)

Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor, higher numbers indicated greater arterial stiffness

Time frame
Baseline
2

Augmentation index (Aix)

Augmentation index (%) measured with SphygmaCor, higher numbers indicated greater arterial stiffness.

Time frame
Baseline
3

Pulse wave velocity (PWV)

Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor

Time frame
5 Years
4

Augmentation index (Aix)

Augmentation index (%) measured with SphygmaCor

Time frame
5 Years

Secondary outcomes

1

Right coronary wall thickness

During cardiac MRI, cross-sectional analysis of right coronary artery vessel wall thickness; greater thickness associated with increased risk for endothelial dysfunction

Time frame
Baseline
2

Right coronary wall thickness

During cardiac MRI, cross-sectional analysis of right coronary artery vessel wall thickness; greater thickness associated with increased risk for endothelial dysfunction

Time frame
5 years
3

Endothelial Function

During cardiac MRI, measurements of change in vessel wall thickness during isometric handgrip exercise. Smaller change associated with endothelial dysfunction

Time frame
Baseline
4

Endothelial Function

During cardiac MRI, measurements of change in vessel wall thickness during isometric handgrip exercise. Smaller change associated with endothelial dysfunction

Time frame
5 years

Other outcomes

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