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Protocol Details

Quantifying Weight Regain and the Persistence of Metabolic Adaptation Following Extreme Weight Loss

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-DK-0192

Sponsoring Institute

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

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Energy Expenditure;
Obesity;
Behavioral Weight Loss Treatment

Recruitment Keyword(s)

None

Condition(s)

Energy Expenditure

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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

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Eligibility

INCLUSION CRITERIA:

- 16 subjects who previously participated in the Biggest Loser study (Pennington Biomedical Research Center protocol no. PBRC29008).

- Written informed consent

EXCLUSION CRITERIA:

- Volunteers unwilling or unable to give informed consent.

- Women who are pregnant or breastfeeding cannot participate in the study. A pregnancy test will be performed during the first day of the inpatient visit. If the pregnancy test is positive, the subject cannot continue to participate in the study.

- Subjects with implantable cardio-defibrillator or pacemaker may not participate in the bioelectric impedance spectroscopy (BIS) testing portion of the study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kevin Hall, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Kevin Hall, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 12A
Room 4007
12 South Drive
Bethesda, Maryland 20892
(301) 402-8248
kevinh@niddk.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02544009

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