Physical Activity Following Surgery Induced Weight Loss
2 other identifiers
interventional
128
1 country
2
Brief Summary
The primary objective of this study will be to determine the effects of physical activity in patients during substantial surgery-induced weight loss. A randomized controlled physical activity intervention trial in a group of patients undergoing bariatric surgery for weight loss. The study will involve two sites with an active bariatric surgery program, which have a strong track record of bariatric surgery research. The study will include 160-200 subjects. Changes in the primary outcome variables will be determined in previous gastric bypass patients as a result of 6 months of moderate physical activity compared to an educational control group not engaged structured exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Dec 2007
Longer than P75 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 4, 2014
November 1, 2014
3.9 years
June 2, 2008
November 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin sensitivity, intramyocellular lipid, total body fat, total lean mass
Twelve months
Secondary Outcomes (1)
Intra-muscular adipose tissue, abdominal fat, mitochondria content, fat oxidation
Twelve months
Study Arms (1)
Exercise
OTHERStructured exercise program
Interventions
1\. Physical activity group: Subjects will be progressed to 4-5 days per week, 30-45 min per session (120-180 min per week) of moderate intensity exercise. 2. Control (educational) group: Subjects will receive their usual care following surgery that in addition to their weight loss.
Eligibility Criteria
You may qualify if:
- Men and women (21-60 years of age) good health, stable weight, and without any contraindication to exercise.
You may not qualify if:
- Anemia (Hct\<34%)
- Elevated liver enzyme (25% above normal),
- Proteinuria,
- Hypothyroidism (sTSH \> 8)
- Hypertension (blood pressure \> 150 mmHg systolic, or \> 95 mmHg diastolic)
- Diabetes mellitus (fasting glucose ≥ 126 mg/dl)
- A history of myocardial infarction or peripheral vascular disease
- Liver disease
- Alcohol or drug abuse
- Malignancy or neuromuscular disease
- Subjects will be excluded if taking chronic medications known to adversely affect glucose homeostasis (oral glucocorticoids, nicotinic acid)
- Females currently on hormone replacement therapy (HRT) can participate in the study if they have been on HRT for at least 6 months and will continue to be on HRT during the study.
- Disqualifying findings on physical examination include:
- Lower extremity thrombophlebitis
- Evidence of peripheral neuropathy, paresis or edema.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- East Carolina Universitycollaborator
Study Sites (2)
East Carolina University
Greenville, North Carolina, 27858, United States
Montefiore Hospital, N807
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (4)
Carnero EA, Dubis GS, Hames KC, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Randomized trial reveals that physical activity and energy expenditure are associated with weight and body composition after RYGB. Obesity (Silver Spring). 2017 Jul;25(7):1206-1216. doi: 10.1002/oby.21864. Epub 2017 May 30.
PMID: 28558160DERIVEDNunez Lopez YO, Coen PM, Goodpaster BH, Seyhan AA. Gastric bypass surgery with exercise alters plasma microRNAs that predict improvements in cardiometabolic risk. Int J Obes (Lond). 2017 Jul;41(7):1121-1130. doi: 10.1038/ijo.2017.84. Epub 2017 Mar 27.
PMID: 28344345DERIVEDCoen PM, Menshikova EV, Distefano G, Zheng D, Tanner CJ, Standley RA, Helbling NL, Dubis GS, Ritov VB, Xie H, Desimone ME, Smith SR, Stefanovic-Racic M, Toledo FG, Houmard JA, Goodpaster BH. Exercise and Weight Loss Improve Muscle Mitochondrial Respiration, Lipid Partitioning, and Insulin Sensitivity After Gastric Bypass Surgery. Diabetes. 2015 Nov;64(11):3737-50. doi: 10.2337/db15-0809. Epub 2015 Aug 20.
PMID: 26293505DERIVEDCoen PM, Tanner CJ, Helbling NL, Dubis GS, Hames KC, Xie H, Eid GM, Stefanovic-Racic M, Toledo FG, Jakicic JM, Houmard JA, Goodpaster BH. Clinical trial demonstrates exercise following bariatric surgery improves insulin sensitivity. J Clin Invest. 2015 Jan;125(1):248-57. doi: 10.1172/JCI78016. Epub 2014 Dec 1.
PMID: 25437877DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bret H Goodpaster, Ph.D.
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 6, 2008
Study Start
December 1, 2007
Primary Completion
November 1, 2011
Study Completion
November 1, 2012
Last Updated
November 4, 2014
Record last verified: 2014-11