Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

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

⁃ 1a.Age 12-25 years

⁃ 1b.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% per American Diabetes Association Criteria and one element from the medical history consistent with ADA or AAP guidelines including: family history of diabetes and obesity, maternal or personal history of gestational diabetes, high-risk race and ethnicity, history of cardiovascular disease, hypertension, dyslipidemia, polycystic ovary syndrome, physical inactivity, other clinical conditions associated with insulin resistance (e.g. severe obesity, acanthosis nigricans, prediabetes), small or large for gestational age birth weight, history of breastfeeding, gestational history of illicit drugs including alcohol, smoking OR documentation of type 2 diabetes diagnosed at \<=25 years of age with verified medical history (as above).

⁃ 2\. Youth with overweight/ obesity (Y-OW)

⁃ 2a. Age 12-25 years

⁃ 2b. For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR

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

⁃ 2d. 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).

⁃ 3\. Healthy control lean participants (Y-Lean)

⁃ 3a. Age 12-25 years

⁃ 3b. For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR

⁃ 3c. For participants \>=18 years of age, BMI 18-24.99 kg/m\^2.

⁃ 3d. HbA1c \<5.7 percent (either during testing at NIH or as previously documented on outside medical record).

⁃ 4\. Biological parents of Y-T2DM, Y-OW and Y-Lean participants

⁃ 4a. 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

Similar Clinical Trials