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Physical Activity Following Surgery Induced Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Body fat, Exercise, Fatty acids, Impaired glucose tolerance, Insulin resistance, Insulin Sensitivity, Metabolic syndrome, Obesity, Physical activity, Weight Loss

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • East Carolina University
  • Montefiore Hospital, N807

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise

Arm Description

Structured exercise program

Outcomes

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

Full Information

First Posted
June 2, 2008
Last Updated
November 2, 2014
Sponsor
University of Pittsburgh
Collaborators
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT00692367
Brief Title
Physical Activity Following Surgery Induced Weight Loss
Official Title
Physical Activity Following Surgery Induced Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
East Carolina University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The primary objective of this study will be to determine the effects of physical activity in patients during substantial surgery-induced weight loss. We propose to employ 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. Recruitment goals are 160-200 gastric bypass patients who will undergo 6 months of moderate physical activity compared to an educational control group not engaged structured exercise. Subjects will be included if their BMI is less than 55 kg/m2 prior to surgery and they are located relatively close to centers for intervention sessions. At baseline (3 months following surgery) and 6 months later (9 months following surgery), subjects will have a CT scan, IV glucose tolerance test (IVGTT) and muscle biopsy (~8 hour visit). They will be scheduled for separate visits for a test of physical fitness (VO2max) and general body composition (DXA scan)(~2 hour visit), and a 15-min sub-maximal exercise session. 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. Control (educational) group: Subjects will receive their usual care following surgery that includes information on physical activity. They will also be asked to participate in monthly health education sessions. We will promote this study as one that will help determine whether physical activity may be beneficial in addition to their weight loss. Aim 1: Insulin resistance and metabolic risk factors. Approach: To address Aim 1, we will determine 6-month changes in insulin sensitivity in subjects after 3-month initial weight loss from bariatric surgery. As outlined above, we will employ a randomized controlled physical activity intervention trial in which half of the subjects will be entered into a physical activity group, while the other half will participate in monthly health education sessions (control). By randomizing these groups three months after initial weight loss, both groups should begin the intervention with similar baseline characteristics (e.g. insulin sensitivity, body weight, physical fitness, etc.). We are not attempting to determine the effect of the weight loss per se on insulin sensitivity. However, we realize that the amount of weight loss could potentially have a major confounding influence on detecting changes in insulin sensitivity between the two groups. Thus, we will examine the degree of weight loss as a covariate in our analyses. Aim 2: Intramyocellular lipids and body composition. Approach: We will examine pre to post intervention, changes in intramyocellular lipid determined with percutaneous biopsies, as well as abdominal and intermuscular adipose tissue determined by CT imaging. Aim 3: Mitochondria content, function and fat oxidation. Approach: We will use three complimentary measures to quantify changes in oxidative metabolism before and after the randomized controlled trial described above. All three of these measures will make specific contributions to this specific aim. Rates of resting post-absorptive fat oxidation will be measured with indirect calorimetry. Since skeletal muscle accounts for the vast majority of energy production during physical activity, sub-maximal exercise is a good model to assess skeletal muscle fatty acid metabolism. We will employ whole body gas exchange indirect calorimetry during moderate exercise designed to elicit high rates of fatty acid oxidation. The non-invasive measures of systemic fat oxidation during both resting and exercise conditions procedures take very little time and present relatively little burden on the volunteers or technical staff, thus providing an efficient means to obtain significant information concerning the capacity for fat oxidation in vivo. Muscle biopsy samples will be obtained before and after the trial to measure changes in the oxidative capacity (electron transport chain activity, in vitro fatty acid oxidation, muscle fiber type and oxidative enzyme (succinate dehydrogenase) staining activity of muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Body fat, Exercise, Fatty acids, Impaired glucose tolerance, Insulin resistance, Insulin Sensitivity, Metabolic syndrome, Obesity, Physical activity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Other
Arm Description
Structured exercise program
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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 Measure Information:
Title
Insulin sensitivity, intramyocellular lipid, total body fat, total lean mass
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Intra-muscular adipose tissue, abdominal fat, mitochondria content, fat oxidation
Time Frame
Twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret H Goodpaster, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Montefiore Hospital, N807
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28558160
Citation
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.
Results Reference
derived
PubMed Identifier
28344345
Citation
Nunez 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.
Results Reference
derived
PubMed Identifier
26293505
Citation
Coen 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.
Results Reference
derived
PubMed Identifier
25437877
Citation
Coen 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.
Results Reference
derived

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Physical Activity Following Surgery Induced Weight Loss

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