Metabolic and Neural Adaptations to Weight Loss, Plateau, and Regain

NCT02199483 | Withdrawn

• 2 other identifiers: 14015414-DK-0154
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Many people can lose weight by changing their diet or exercise. However, most people eventually regain the weight over time. This weight regain may be related to changes in metabolism as well as changes in the brain caused by weight loss. Researchers want to learn more about these changes. Objective: \- To see how weight loss and regain affects the body s metabolism and the brain of obese but healthy adults. Eligibility: \- Obese but healthy adults age 18-55 who plan to participate in a weight loss program at one of several participating clinics or resorts. Design:

• Participants will first be screened at home through questionnaires and telephone interviews.
• Participants will then be screened at the NIH with blood tests, medical history, physical exam, electrocardiograms, and questionnaires. They will have a mock magnetic resonance imaging (MRI) scan.
• At visit 1, participants will stay at the NIH and will:
• have MRI and PET brain scans.
• have body composition scans and measurements.
• give blood samples.
• eat a special diet.
• wear a physical activity monitor.
• provide a urine sample and body weight daily.
• drink a special type of water to measure calorie burn.
• wear a clear plastic hood over their head while lying down, to collect exhaled air.
• spend 24 hours in a room that measures oxygen and carbon dioxide.
• complete questionnaires and computer tasks.
• After visit 1, participants will give daily urine samples and weight and physical activity measurements from home. Then they will follow a lifestyle intervention for weight loss and give daily weight and activity measurements.
• Visits 2, 3, and 4 occur 1-26 months after the start of the weight loss program. Participants will repeat procedures from visit 1. Visits 1-4 last 4 days each.
• Researchers will track participants weight and physical activity for up to 26 months after visit 2.

Conditions

Healthy Volunteers

Keywords

Energy Expenditure; Behavioral Weight Loss Treatment; Neurocognitive Function; Weight Loss

Outcome Measures

Primary Outcomes (1)

• To measure metabolic and neural adaptations after 4-12 weeks, 6-10 months, and 22-26 months following the start of a lifestyle intervention resulting in weight loss.

  ongoing

Secondary Outcomes (2)

• To determine whether the degree of metabolic or neural adaptation at 4-12 weeks is correlated with the weight plateau at 6-10 months or the rate of weight regain in the subsequent months.

  ongoing

• To investigate changes in circulating hormone and metabolites that correlate with metabolic and neural adaptations as well as changes in appetitive behaviors following a lifestyle intervention resulting in weight loss.

  ongoing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-55 years, male and female
• Recent weight stability (\< plus and minus 2 % over past 1 month)
• Body mass index (BMI) greater than or equal to 30 kg/m2
• Able to complete daily bouts of moderate to vigorous exercise (when applicable)
• Written informed consent
• Have reserved a stay of at least 4 weeks at The Biggest Loser Resort or have enrolled in a structured meal replacement weight loss program at the Washington Center for Weight Management and Research, the National Center for Weight and Wellness, or the Johns Hopkins Weight Management Center.

You may not qualify if:

• Body weight \> 400 lbs (weight limit of PET and MRI scanners)
• BMI \< 30 kg/m2
• Less than 80% of maximum lifetime weight
• Hypertension if
• (1) \>160/100;
• (2) 140/90 to 159/99 with evidence of target organ damage (e.g. elevated serum creatinine, proteinuria, abnormal EKG, retinopathy);
• (3) \>140/90 on antihypertensive medications.
• Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
• Past or present history of eating disorder (including binge eating) or psychiatric disease
• Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
• Hematocrit \< 34% (women only)
• Hematocrit \< 40% (men only)
• Pregnancy, lactation (women only)
• Women who become pregnant during the two-year study period
• Recent participation in a regular exercise program (\> 4h/week of vigorous activity)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Related Publications (3)

• Franz MJ, VanWormer JJ, Crain AL, Boucher JL, Histon T, Caplan W, Bowman JD, Pronk NP. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc. 2007 Oct;107(10):1755-67. doi: 10.1016/j.jada.2007.07.017.

  PMID: 17904936 BACKGROUND

• Arone LJ, Mackintosh R, Rosenbaum M, Leibel RL, Hirsch J. Autonomic nervous system activity in weight gain and weight loss. Am J Physiol. 1995 Jul;269(1 Pt 2):R222-5. doi: 10.1152/ajpregu.1995.269.1.R222.

  PMID: 7631897 BACKGROUND

• Johannsen DL, Knuth ND, Huizenga R, Rood JC, Ravussin E, Hall KD. Metabolic slowing with massive weight loss despite preservation of fat-free mass. J Clin Endocrinol Metab. 2012 Jul;97(7):2489-96. doi: 10.1210/jc.2012-1444. Epub 2012 Apr 24.

  PMID: 22535969 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Hall, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 24, 2014
• Study Start: July 21, 2014
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: December 12, 2019

Record last verified: 2017-06-29