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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07388537
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
Nov 30, 2054
Completion
Apr 30, 2055

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

To collect data and samples during clinical evaluation, treatment, and follow-up of participants for use in future studies. [ Time Frame: Up to 30 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Noemi Malandrino, M.D.
[email protected]
301-402-4006
Lilian Mabundo
[email protected]
(240) 383-9379

Find similar trials in Bethesda, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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