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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 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.

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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

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2015-09-05
Est. Completion 2016-05-19

What the Registry Record Tells You About NCT02544009

The ClinicalTrials.gov registry entry for NCT02544009 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 92-participant average among 6 other Energy Expenditure trials with a reported enrollment target (84% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Energy Expenditure appearing as the primary indexed condition, and to 0 interventions.

NCT02544009 reports 1 study location spanning 1 distinct geographic area - top geographies include 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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