Bethesda, MDNCT06730113Now EnrollingIRB Ready

Obesity Clinical Trial in Bethesda, MD

Access cutting-edge obesity treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

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

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related obesity treatment provided free

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Check if you qualify for this obesity clinical trial in Bethesda, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Obesity Study in Bethesda

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. ...

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

Who Can Participate

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 1a.Age 12-25 years 1b.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% per American Diabetes Association Criteria and one element from the medical history consistent with ADA or AAP guidelines including: family history of diabetes and obesity, maternal or personal history of gestational diabetes, high-risk race and ethnicity, history of cardiovascular disease, hypertension, dyslipidemia, polycystic ovary syndrome, physical inactivity, other clinical conditions associated with insulin resistance (e.g. severe obesity, acanthosis nigricans, prediabetes), small or large for gestational age birth weight, history of breastfeeding, gestational history of illicit drugs including alcohol, smoking OR documentation of type 2 diabetes diagnosed at \<=25 years of age with verified medical history (as above). 2\. Youth with overweight/ obesity (Y-OW) 2a. Age 12-25 years 2b. For participants \< 18 years of age, BMI \>= 85th percentile (overweight) and \>= 95th percentile (obesity) for age and sex OR 2c. For participants \>= 18 years of age, BMI \>=25\<30 kg/m\^2 (overweight) or \>=30 kg/m\^2 (obesity) 2d. 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). 3\. Healthy control lean participants (Y-Lean) 3a. Age 12-25 years 3b. For participants \< 18 years of age, BMI \<= 85th percentile for age and sex OR 3c. For participants \>=18 years of age, BMI 18-24.99 kg/m\^2. 3d. HbA1c \<5.7 percent (either during testing at NIH or as previously documented on outside medical record). 4\. Biological parents of Y-T2DM, Y-OW and Y-Lean participants 4a. 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: 1\. Y-T2DM, Y-OW and Y-Lean Participants: 1a. Type 1 diabetes or the presence of \>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).
b. 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). 1c. 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). 1d. For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals. 1e. Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration. 1f. Pregnancy at the time of the screening visit. 1g. Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.
h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above. 2\. 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: 2a. 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. 2b. Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice) 2c. History of diabetes or abnormal glucose tolerance 2d.. Abnormal screening labs, including the following: i) ALT or AST \>2 times the upper limit of normal ii) Glycosuria iii) 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 2e. Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above. 3\. Biological Parents -No Exclusion Criteria

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT06730113) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obesity Treatment Options in Bethesda, MD

If you're searching for obesity treatment options in Bethesda, MD, this clinical trial (NCT06730113) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obesity specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obesity clinical trials near you to find additional studies recruiting in your area.

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