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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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. ...

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 25
Healthy Volunteers: t
View:

∙ To be eligible to participate in this study, an individual must meet the following criteria according to their group:

∙ Four categories of participants will be included in this study and the inclusion criteria for each group are given below:

• Participants with Y-T2DM

‣ Age 12-25 years

⁃ Type 2 diabetes mellitus as defined by fasting blood glucose \>= 126 mg/dL OR postprandial blood sugar \>= 200 mg/dL OR Hemoglobin A1c \>= 6.5 percent per American Diabetes Association Criteria OR documentation of type 2 diabetes diagnosed at \<=25 years of age

• Youth with overweight/ obesity (Y-OW)

‣ Age 12-25 years

⁃ For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR

⁃ For participants \>= 18 years of age, BMI \>=25\<30 kg/m\^2 (overweight) or \>=30 kg/m\^2 (obesity)

⁃ Participants with obesity may have a diagnosis of prediabetes, defined as fasting blood glucose 100-125 mg/dL OR postprandial blood sugar 140-199 mg/dL OR HbA1c 5.7-6.4 percent (either during testing at NIH or as previously documented on outside medical record).

• Healthy control lean participants (Y-Lean)

‣ Age 12-25 years

⁃ For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR

⁃ For participants \>=18 years of age, BMI 18-24.99 kg/m\^2.

⁃ HbA1c \<5.7 percent (either during testing at NIH or as previously documented on outside medical record).

• Biological parents of Y-T2DM, Y-OW and Y-Lean participants

‣ Biological parent of enrolled Y-T2DM, Y-OW and Y-Lean by self-report.

Locations
United States
Washington, D.c.
Children's National Hospital (CNH)
RECRUITING
Washington D.c.
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Lilian S Mabundo
lilian.mabundo@nih.gov
(240) 383-9379
Backup
Stephanie T Chung, M.D.
stephanie.chung@nih.gov
(240) 479-8137
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2033-10-31
Participants
Target number of participants: 930
Treatments
Healthy control lean participants (Y-Lean)
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).
Y-T2DM
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).
Youth with overweight/ obesity (Y-OW
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).
Related Therapeutic Areas
Sponsors
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov