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Exercise Dose-Response on Features of the Metabolic Syndrome

Primary Purpose

Insulin Resistance, Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-intensity treadmill exercise
Moderate-intensity treadmill exercise
Non-aerobic stretching exercise
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Insulin resistance, Metabolic syndrome, Aerobic exercise, Exercise behavior

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females, age 18-60
  • At least 2 of the 5 components of the NCEP definition of the metabolic syndrome, provided that either the triglyceride or waist circumference criteria are met
  • Body mass index of 25-45 kg/m2
  • Subjects not currently following a regular exercise program nor an optimal diet, and who self-report their activity level as sedentary
  • Able to understand and sign the informed consent form, follow the instructions given in the study, attend all necessary clinic visits, and undergo all required study procedures

Exclusion Criteria:

  • Past or current diabetes mellitus
  • Significant concurrent medical illnesses (chronic liver or renal disease, malignancies, recent or chronic infections including HIV, surgeries or other hospitalizations within four weeks prior to screening), uncontrolled hypertension (BP >160/90 mm Hg), or abnormal TSH on screening.
  • Conditions that may contraindicate physical activity (clinically significant cardiac, pulmonary, orthopedic, rheumatological or neurological diseases)
  • Cardiovascular disease not controlled with medical therapy, or invasive vascular procedures within six months prior to screening
  • Subjects found on resting EKG or stress testing to have underlying cardiac abnormalities
  • Perimenopausal women who are experiencing irregular menses
  • Pregnant or lactating women
  • Subjects who may have limited exercise tolerance because of treatment with β-adrenergic blockade agents, at least until agents of alternate drug classes can be substituted
  • Subjects with concurrent endocrinopathies
  • Subjects receiving concurrent treatment with metformin, thiazolidinediones, systemic glucocorticoids, or any weight loss agents
  • Subjects who expect to require medications during the course of the study that may affect their metabolic profile, including systemic glucocorticoids and hormone replacement therapies
  • Subjects who cannot complete the stress test due to physical limitations
  • Any other factors that, in the opinion of the investigators, may interfere with the safe conduct, the successful completion, or the quality of the data obtained from the study

Sites / Locations

  • Charles Drew University of Medicine and Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Low-intensity aerobic exercise

Moderate-intensity aerobic exercise

Non-aerobic stretching exercise

Outcomes

Primary Outcome Measures

Insulin sensitivity (clamp)

Secondary Outcome Measures

Aerobic fitness (VO2Max, Anaerobic threshold, endurance time)
Body mass index, waist circumference
Fat mass, fat-free mass, lean body mass (DEXA)
Blood pressure
Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index
Fasting lipid profile
Apolipoprotein B
Highly-sensitive C-reactive protein
Exercise behavior questionnaire scores
Any adverse events

Full Information

First Posted
May 27, 2008
Last Updated
February 24, 2012
Sponsor
Charles Drew University of Medicine and Science
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00687128
Brief Title
Exercise Dose-Response on Features of the Metabolic Syndrome
Official Title
Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Drew University of Medicine and Science
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates the degree of improvement in insulin resistance and features of the metabolic syndrome in non-diabetic overweight or obese subjects after training in a low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated exercise behavior after the assigned exercise program.
Detailed Description
The proposed study is a randomized, open study comparing low-intensity and moderate-intensity aerobic exercise versus non-aerobic (stretching) exercise on direct measurements of insulin resistance and variables associated with the metabolic syndrome. This 6-month intervention will be followed by an additional 6-month follow-up period during which subjects will be encouraged to maintain their exercise regimen (along with their prescribed diet) but without scheduled supervision. Behavioral variables associated with adherence will be analyzed along with changes in the above physiological variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Metabolic Syndrome, Obesity
Keywords
Insulin resistance, Metabolic syndrome, Aerobic exercise, Exercise behavior

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Low-intensity aerobic exercise
Arm Title
2
Arm Type
Experimental
Arm Description
Moderate-intensity aerobic exercise
Arm Title
3
Arm Type
Active Comparator
Arm Description
Non-aerobic stretching exercise
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity treadmill exercise
Other Intervention Name(s)
"Casual" walking program
Intervention Description
Treadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-intensity treadmill exercise
Other Intervention Name(s)
"Brisk" walking program
Intervention Description
Treadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
Intervention Type
Behavioral
Intervention Name(s)
Non-aerobic stretching exercise
Other Intervention Name(s)
Non-aerobic control
Intervention Description
Floor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive.
Primary Outcome Measure Information:
Title
Insulin sensitivity (clamp)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Aerobic fitness (VO2Max, Anaerobic threshold, endurance time)
Time Frame
6 and 12 months
Title
Body mass index, waist circumference
Time Frame
6 and 12 months
Title
Fat mass, fat-free mass, lean body mass (DEXA)
Time Frame
6 and 12 months
Title
Blood pressure
Time Frame
6 and 12 months
Title
Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index
Time Frame
6 and 12 months
Title
Fasting lipid profile
Time Frame
6 and 12 months
Title
Apolipoprotein B
Time Frame
6 and 12 months
Title
Highly-sensitive C-reactive protein
Time Frame
6 and 12 months
Title
Exercise behavior questionnaire scores
Time Frame
6 and 12 months
Title
Any adverse events
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, age 18-60 At least 2 of the 5 components of the NCEP definition of the metabolic syndrome, provided that either the triglyceride or waist circumference criteria are met Body mass index of 25-45 kg/m2 Subjects not currently following a regular exercise program nor an optimal diet, and who self-report their activity level as sedentary Able to understand and sign the informed consent form, follow the instructions given in the study, attend all necessary clinic visits, and undergo all required study procedures Exclusion Criteria: Past or current diabetes mellitus Significant concurrent medical illnesses (chronic liver or renal disease, malignancies, recent or chronic infections including HIV, surgeries or other hospitalizations within four weeks prior to screening), uncontrolled hypertension (BP >160/90 mm Hg), or abnormal TSH on screening. Conditions that may contraindicate physical activity (clinically significant cardiac, pulmonary, orthopedic, rheumatological or neurological diseases) Cardiovascular disease not controlled with medical therapy, or invasive vascular procedures within six months prior to screening Subjects found on resting EKG or stress testing to have underlying cardiac abnormalities Perimenopausal women who are experiencing irregular menses Pregnant or lactating women Subjects who may have limited exercise tolerance because of treatment with β-adrenergic blockade agents, at least until agents of alternate drug classes can be substituted Subjects with concurrent endocrinopathies Subjects receiving concurrent treatment with metformin, thiazolidinediones, systemic glucocorticoids, or any weight loss agents Subjects who expect to require medications during the course of the study that may affect their metabolic profile, including systemic glucocorticoids and hormone replacement therapies Subjects who cannot complete the stress test due to physical limitations Any other factors that, in the opinion of the investigators, may interfere with the safe conduct, the successful completion, or the quality of the data obtained from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Hsia, MD
Organizational Affiliation
Charles Drew University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles Drew University of Medicine and Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cdrewu.edu/
Description
News item regarding the study. Click here for more information about the study: Dose-Response Effects of Aerobic Exercise on Insulin Resistance and the Metabolic Syndrome

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Exercise Dose-Response on Features of the Metabolic Syndrome

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