Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001819-DK

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: 25 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women

Keywords

Cardiovascular Disease;
Overweight;
Obesity;
Youth Onset Type 2 Diabetes;
Lean

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Type 2 Diabetes

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria for their specific group will be excluded from participation in this study:

-Y-T2DM, Y-OW and Y-Lean Participants:

--Type 1 diabetes or the presence of >2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).

--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).

--Serious medical illnesses or diseases thought to alter metabolism (including moderate to severe renal disease (< 30 mL/min/1.73m^2), congenital heart disease, Cushing s syndrome, cancer, or other metabolic diseases associated with diabetes or excess weight).

--For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.

--Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.

--Pregnancy at the time of the screening visit.

--Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.

-Y-Lean participants:

In addition to the above exclusion criteria, any Y-Lean participant who meets any of the following additional criteria will be excluded from the study:

--Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.

--Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)

--History of diabetes or abnormal glucose tolerance

--Abnormal screening labs, including the following:

---ALT or AST >2 times the upper limit of normal

---Glycosuria

---Low eGFR (<90 mL/min/1.73m^2)Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data

-Biological Parents

--No Exclusion Criteria


Citations:

Not Provided

Contacts:

Principal Investigator

Referral Contact

For more information:

Stephanie T. Chung, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CRC BG RM 5-5940
10 CENTER DR
BETHESDA MD 20892
(240) 479-8137
stephanie.chung@nih.gov
Lilian S. Mabundo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-5750
10 Center Drive
Bethesda, Maryland 20892
(240) 383-9379
lilian.mabundo@nih.gov
Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06730113
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