Physical Activity Following Surgery Induced Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
East Carolina University
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00692367
First received: June 2, 2008
Last updated: April 2, 2010
Last verified: April 2010
  Purpose

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 Intervention
Obesity
Behavioral: Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Activity Following Surgery Induced Weight Loss

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Insulin sensitivity, intramyocellular lipid, total body fat, total lean mass [ Time Frame: Twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-muscular adipose tissue, abdominal fat, mitochondria content, fat oxidation [ Time Frame: Twelve months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2007
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Krista Clark, MS, RD, LDN 412-692-2415 clarkk@dom.pitt.edu
Contact: Nicole Helbling, MS, RN 412-692-2285 rasmussenn@dom.pitt.edu

Locations
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
Principal Investigator: Joseph Houmard, PhD         
United States, Pennsylvania
Montefiore Hospital, N807 Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Krista Clark    412-692-2415    clarkk@dom.pitt.edu   
Contact: Nicole Helbling    412-692-2285    rasmussenn@dom.pitt.edu   
Principal Investigator: Bret H Goodpaster, PhD         
Sponsors and Collaborators
University of Pittsburgh
East Carolina University
Investigators
Principal Investigator: Bret H Goodpaster, Ph.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Bret H. Goodpaster, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00692367     History of Changes
Other Study ID Numbers: PRO007090041, R01 DK078192-01A1
Study First Received: June 2, 2008
Last Updated: April 2, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 28, 2014