Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

8 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

1000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Background:

Diabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.

Objective:

To collect data and samples regularly from people with obesity and diabetes.

Eligibility:

People aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.

Design:

Participants will have additional procedures during routine care visits at the NIH clinic.

Data collected for the study will include the following:

Information from the participant s medical chart will be kept for research.

Questionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.

Blood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.

Data and samples will be kept for future research.

Participants may remain in the study up to 30 years.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age 8 years to 65 years
2. Meet at least one of the following:

a. Overweight/Obesity:

i. For participants under 18 years of age: BMI \>= 85th percentile for age and sex

ii. For participants \>= 18 years of age: BMI \>= 25 kg/m\^2 (\>=23 kg/m\^2 for self-reported Asian race/ethnicity)

b. Suspected or evidence of hyperglycemia:

i. Diagnosis of prediabetes or diabetes in medical history or by participant/guardian/Legally Authorized Representative (LAR) report, OR

ii. Fasting blood glucose \>= 100 mg/dL in medical record, OR

iii. Postprandial blood sugar \>= 140 mg/dL in medical record, OR

iv. Hemoglobin A1c \>= 5.7% in medical record

EXCLUSION CRITERIA:

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

1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.
2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.
3. Inability or unwillingness of participant, parent/guardian, or LAR to provide informed consent.

Study population

This is a single-site observational study conducted at the NIH Clinical Center. Youth and adults who have suspected or established hyperglycemia, overweight or obesity, or metabolic disease, or who require clinical screening for such conditions are provided standard clinical care. Data and samples obtained during regular clinical care will be retained for future research. Recommendations for other treatment options outside of the NIH will be discussed with study participants and may be discussed with their primary or referring physicians. The schedule a participant follows will be based on their unique clinical needs.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

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

Study start

Nov 15, 2026 Estimated

Primary completion

Nov 30, 2054 Estimated

Study completion

Apr 30, 2055 Estimated

First posted

Feb 5, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts