We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Exercise Dose-Response on Features of the Metabolic Syndrome

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.
ClinicalTrials.gov Identifier: NCT00687128
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Insulin Resistance Metabolic Syndrome Obesity Behavioral: Low-intensity treadmill exercise Behavioral: Moderate-intensity treadmill exercise Behavioral: Non-aerobic stretching exercise

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome
Study Start Date : October 2004
Primary Completion Date : September 2009
Study Completion Date : April 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Low-intensity aerobic exercise
Behavioral: Low-intensity treadmill exercise
Treadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
Other Name: "Casual" walking program
Experimental: 2
Moderate-intensity aerobic exercise
Behavioral: Moderate-intensity treadmill exercise
Treadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.
Other Name: "Brisk" walking program
Active Comparator: 3
Non-aerobic stretching exercise
Behavioral: Non-aerobic stretching exercise
Floor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive.
Other Name: Non-aerobic control

Outcome Measures

Primary Outcome Measures :
  1. Insulin sensitivity (clamp) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Aerobic fitness (VO2Max, Anaerobic threshold, endurance time) [ Time Frame: 6 and 12 months ]
  2. Body mass index, waist circumference [ Time Frame: 6 and 12 months ]
  3. Fat mass, fat-free mass, lean body mass (DEXA) [ Time Frame: 6 and 12 months ]
  4. Blood pressure [ Time Frame: 6 and 12 months ]
  5. Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index [ Time Frame: 6 and 12 months ]
  6. Fasting lipid profile [ Time Frame: 6 and 12 months ]
  7. Apolipoprotein B [ Time Frame: 6 and 12 months ]
  8. Highly-sensitive C-reactive protein [ Time Frame: 6 and 12 months ]
  9. Exercise behavior questionnaire scores [ Time Frame: 6 and 12 months ]
  10. Any adverse events [ Time Frame: 6 and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00687128

United States, California
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Center for Research Resources (NCRR)
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
More Information

Additional Information:
Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00687128     History of Changes
Other Study ID Numbers: 04-10-788
U54RR014616 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Charles Drew University of Medicine and Science:
Insulin resistance
Metabolic syndrome
Aerobic exercise
Exercise behavior

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases