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New treatment option for Overweight and Obesity
Official title Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
ClinicalTrials.gov ID: NCT04583514
What this study is testing
- What it's testing
- Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 42. Healthy volunteers may be eligible.
You may be able to join if
- Men and pre-menopausal women
- 18-42 years of age
- BMI 23-35 kg/m2 (± 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
- Are willing to be assigned by chance to either a CTL or 30% OF group
You likely can't join if
- Unstable weight in the last 3 months (± \~5% weight change)
- Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose \> 110 mg/dL
- Average screening blood pressure \> 140/90 mmHg
- Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI...
- Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
- Any current or previous eating disorders
See the full eligibility criteria
- Men and pre-menopausal women
- 18-42 years of age
- BMI 23-35 kg/m2 (± 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
- Are willing to be assigned by chance to either a CTL or 30% OF group
- For women, if not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), must agree to use either a double barrier method as a form of birth control to prevent...
- Must be willing to adhere to all study procedures, including attendance at all study visits
- If enrolled, agree to maintain the same level of physical activity throughout the duration of the study
- Must be willing to have blood stored for future research
- Unstable weight in the last 3 months (± \~5% weight change)
- Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose \> 110 mg/dL
- Average screening blood pressure \> 140/90 mmHg
- Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI, clinically significant and represent a problem for study inclusion.
- Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
- Any current or previous eating disorders
- Chronic use of systemic glucocorticoids (steroids), systemic adrenergic-stimulating agents, beta-blockers, antipsychotic medications, thiazolidinediones and other medications that may cause clinically significant weight...
- Chronic use of prescription weight loss medications or over the counter weight loss medications which, in the opinion of the MI, will impact the study
- Chronic use of anti-depressant medications for less than 3 months
- Chronic smokers or users of tobacco products who cannot abstain for the duration of the inpatient visits
- Previous bariatric or other surgeries for obesity
- Had cancer in the last 5 years (some skin cancers acceptable)
- Pregnancy, breastfeeding, or planned pregnancy for the upcoming 6 months
- Partial or full hysterectomy
- PCOS
- Diagnosed psychotic conditions.
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 42 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.