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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pulse wave velocity (PWV)
Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor, higher numbers indicated greater arterial stiffness
Augmentation index (Aix)
Augmentation index (%) measured with SphygmaCor, higher numbers indicated greater arterial stiffness.
Pulse wave velocity (PWV)
Carotid-femoral pulse wave velocity (m/s) measured with SphygmaCor
Augmentation index (Aix)
Augmentation index (%) measured with SphygmaCor
Secondary outcomes
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
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
Endothelial Function
During cardiac MRI, measurements of change in vessel wall thickness during isometric handgrip exercise. Smaller change associated with endothelial dysfunction
Endothelial Function
During cardiac MRI, measurements of change in vessel wall thickness during isometric handgrip exercise. Smaller change associated with endothelial dysfunction
Sponsors and contacts
Click on the lead sponsor to view all of their trials.