Exercise Dose-Response on Features of the Metabolic Syndrome

February 24, 2012 updated by: Charles Drew University of Medicine and Science

Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90059
        • Charles Drew University of Medicine and Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • "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 Names:
  • "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 Names:
  • Non-aerobic control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity (clamp)
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles Drew University of Medicine and Science

Collaborators

National Center for Research Resources (NCRR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

May 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 24, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-10-788
  • U54RR014616 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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