Physical Activity Following Surgery Induced Weight Loss

The primary objective of this study will be to determine the effects of physical activity in patients during substantial surgery-induced weight loss. A randomised 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.

Official Title

Physical Activity Following Surgery Induced Weight Loss.

Conditions

• Obesity

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• Insulin sensitivity, intramyocellular lipid, total body fat, total lean mass

Secondary Outcome Measures:

• Intra-muscular adipose tissue, abdominal fat, mitochondria content, fat oxidation

Study Start

December 2007

Eligibility & Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Genders Eligible for Study: Both
• 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:

• Anaemia (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

Total Enrolment

200

Contact Details

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692367

Contacts

Krista Clark, MS, RD, LDN 
412-692-2415
clarkk@dom.pitt.edu    

Nicole Helbling, MS, RN
412-692-2285 
rasmussenn@dom.pitt.edu    

Locations

East Carolina University
Greenville, North Carolina
United States, 27858              
     
Montefiore Hospital, N807 
Pittsburgh, Pennsylvania
United States, 15213 

Sponsors and Collaborators

University of Pittsburgh

East Carolina University

Investigators

Principal Investigator:      

Bret H Goodpaster, PhD
University of Pittsburgh

Joseph Houmard, PhD
East Carolina University