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

National Institutes of Health (NIH)

Status: Begins enrollment this month

Conditions: Diabetes; Metabolic Disorders; Obesity

Study type: Observational

Funder types: NIH

Identifiers

NCT07388537

10002229

002229-DK

Details and patient eligibility

About

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.

Full description

Study Description:

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.

Objectives:

To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 8 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

1,000 participants in 2 patient groups

Adults with suspected or established hyperglycemia, overweight or obesity, or metabolic disease

Description:

Data and samples will be obtained during complete comprehensive clinical screening procedures and provision of standard of care treatments. Data and samples to be retained may include either residual samples/ data not otherwise needed for clinical care or additional samples/ data collected during the course of clinical care. These data will provide information to prevent the development and/or progression of cardiovascular disease and other diabetes-related complications, to increase the understanding of these disease processes in patients with different age of onset of metabolic disease, and how available treatments affect the prognosis in these patients.

Youth with suspected or established hyperglycemia, overweight or obesity, or metabolic disease

Description:

Data and samples will be obtained during complete comprehensive clinical screening procedures and provision of standard of care treatments. Data and samples to be retained may include either residual samples/ data not otherwise needed for clinical care or additional samples/ data collected during the course of clinical care. These data will provide information to prevent the development and/or progression of cardiovascular disease and other diabetes-related complications, to increase the understanding of these disease processes in patients with different age of onset of metabolic disease, and how available treatments affect the prognosis in these patients.