Physical Activity Following Surgery Induced Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692367
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : November 4, 2014
East Carolina University
Information provided by (Responsible Party):
Bret Goodpaster, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Physical Activity Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity Following Surgery Induced Weight Loss
Study Start Date : December 2007
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Structured exercise program
Behavioral: Physical Activity
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.

Primary Outcome Measures :
  1. Insulin sensitivity, intramyocellular lipid, total body fat, total lean mass [ Time Frame: Twelve months ]

Secondary Outcome Measures :
  1. Intra-muscular adipose tissue, abdominal fat, mitochondria content, fat oxidation [ Time Frame: Twelve months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women (21-60 years of age) good health, stable weight, and without any contraindication to exercise.

Exclusion Criteria:

  • 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.

If the resting EKG prior to the exercise test shows any abnormalities, the test will not be conducted. If any abnormalities develop during the test, the test will be stopped. On both occasions, the participant will be referred to their PCP for further evaluation and will only be allowed to continue the study with written clearance by his/her PCP or cardiologist. American College of Sports Medicine (ACSM) criteria will be used to halt maximal exercise testing should adverse cardiovascular responses develop. Only after a cardiologist interprets the resting and exercise ECG of the participant and clears them for exercise, will subjects be able to continue with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692367

United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27858
United States, Pennsylvania
Montefiore Hospital, N807
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
East Carolina University
Principal Investigator: Bret H Goodpaster, Ph.D. University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bret Goodpaster, Professor, University of Pittsburgh Identifier: NCT00692367     History of Changes
Other Study ID Numbers: PRO007090041
R01DK078192-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Bret Goodpaster, University of Pittsburgh:
Body fat
Fatty acids
Impaired glucose tolerance
Insulin resistance
Insulin Sensitivity
Metabolic syndrome
Physical activity
Weight Loss

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms