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

NCT07388537 | Not Yet Recruiting

• 2 other identifiers: 10002229002229-DK
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Obesity; Metabolic Disorders

Keywords

Clinical Spectrum of Diabetes; Obesity; Hyperglycemia; Metabolic Disease

Outcome Measures

Primary Outcomes (1)

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

  Samples including whole blood, saliva/buccal swabs, urine, and/or stool will be collected and stored for use in future studies to test our hypothesis that individuals with youth and adult early-onset diabetes and obesity will have high rates of metabolic complications and rapid disease progression compared to adults who develop diabetes later in their life. These samples will be collected during the participants' clinical care visits

  Up to 30 years

Study Arms (2)

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

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

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.

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Age 8 years to 65 years
• 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

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• 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.
• Inability or unwillingness of participant, parent/guardian, or LAR to provide informed consent.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Metabolic Diseases; Hyperglycemia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Noemi Malandrino, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noemi Malandrino, M.D.

CONTACT

(301) 402-4006; noemi.malandrino@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): November 30, 2054
• Study Completion (Estimated): April 30, 2055
• Last Updated: April 16, 2026

Record last verified: 2026-01-28

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Scientific data will be shared as soon as possible. Scientific data included in published manuscript will be available at the time of publication. All other generated data will be shared no later than at the end of the award.
• Access Criteria: The study protocol, data dictionary and a glossary of domain-specific terms to facilitate interpretation of scientific data related to primary outcomes will be submitted.

Locations

US (1)