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NCT04583514 · ClinicalTrials.gov registry record · NA
Testing the Adipose Expandability Hypothesis in Vivo During Overfeeding
A NA study of Overweight and Obesity and Metabolic Syndrome, sponsored by Pennington Biomedical Research Center.
- Recruiting
- Registry status
- NA
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04583514: Recruiting NA study of Overweight and Obesity and Metabolic Syndrome, sponsored by Pennington Biomedical Research Center.
NCT04583514 is a NA study of Overweight and Obesity and Metabolic Syndrome that is actively recruiting participants, run by Pennington Biomedical Research Center. The registered enrollment target is 58 participants, below the 228-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583514, a NA study of Overweight and Obesity and Metabolic Syndrome, is actively recruiting participants, sponsored by Pennington Biomedical Research Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
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). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.
Primary Outcome
Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. The primary outcome is to assess changes in new adipocyte formation in vivo and other mechanisms of adipose expansion and remodeling in response to 30% overfeeding (OF group) relative to the weight-stable CTL group.
Conditions Studied
Interventions
- BEHAVIORAL Control
- BEHAVIORAL Overfeeding
Study Locations (1)
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT04583514 shows while recruiting
NCT04583514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 228-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Overweight and Obesity appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT04583514 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT04583514 about?
NCT04583514 is a clinical study titled "Testing the Adipose Expandability Hypothesis in Vivo During Overfeeding". 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...
What is the current status of trial NCT04583514?
This trial is currently recruiting. It is a NA study. The enrollment target is 58 participants. The study started on 2020-09-15. Estimated completion is 2025-12-31.
What conditions does trial NCT04583514 study?
This clinical trial studies the following conditions: Overweight and Obesity, Metabolic Syndrome.
What interventions are being tested in trial NCT04583514?
The interventions under investigation include: Control (BEHAVIORAL), Overfeeding (BEHAVIORAL).
Who is sponsoring clinical trial NCT04583514?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04583514 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04583514's enrollment target sits among peer trials
58 83rd of 115 higher than 32 of 115 other Overweight and Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overweight and Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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