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NCT02544009 · ClinicalTrials.gov registry record
Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss
A clinical trial of Energy Expenditure, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 15
- Enrollment target
- 1
- Study location
NCT02544009: Completed study of Energy Expenditure, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02544009 is a study of Energy Expenditure that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 15 participants, below the 92-participant average among 6 other Energy Expenditure trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02544009, a study of Energy Expenditure, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Many people regain the weight they lose through diet and exercise. This might happen because the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may cause people to regain weight if they do not keep up high levels of exercise or major caloric restrictions. Researchers want to find the long-term effects of metabolic adaptation in the previous Biggest Loser study participants. They hope to learn the body s response to lifestyle changes that result in weight loss. They also want to see if certain changes can lead to longer-term success in maintaining weight loss. Objectives: To better understand the long-term metabolic changes caused by rapid weight loss achieved through diet restriction and vigorous physical activity. Eligibility: Former Biggest Loser research study participants (Protocol No. PBRC29008). Design: Participants will be screened with a phone interview. This study has 3 phases. Phase 1 will last at least 3 weeks. Participants will receive a physical activity monitor and wireless scale. These will send their daily weight and activity back to NIH. In Phase 2, participants will stay at NIH for 3 days. Their metabolism will be measured through: Their activity monitor Urine samples and daily body weight Medical review and physical exam Fasting for 12 hours each night for a blood draw the following morning DEXA: a low-dose x-ray of the body BIS: Electrodes on the hand/wrist and foot/ankle measure body water content. Phase 3 will last at least 3 weeks. Participants will: Continue to monitor their daily weight and activity Collect urine samples and send them back to NIH
Primary Outcome
The primary analysis will use a t-test to test the null hypothesis that this difference is equal to zero. Secondary analyses will explore predictors of metabolic adaptation.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-09-05 |
| Est. Completion | 2016-05-19 |
What the finished NCT02544009 record still lists
NCT02544009 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 92-participant average among 6 other Energy Expenditure trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Energy Expenditure appearing as the primary indexed condition, and to 0 interventions.
NCT02544009 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02544009 about?
NCT02544009 is a clinical study titled "Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss". Background: Many people regain the weight they lose through diet and exercise. This might happen because the weight loss slows their metabolism. This slowing is called metabolic adaptation. It may cause people to regain weight if they do not keep up high levels of exercise or major caloric restrict...
What is the current status of trial NCT02544009?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2015-09-05. Estimated completion is 2016-05-19.
What conditions does trial NCT02544009 study?
This clinical trial studies the following conditions: Energy Expenditure.
Who is sponsoring clinical trial NCT02544009?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02544009 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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