Exercise Dose-Response on Features of the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00687128
First received: May 27, 2008
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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 Intervention
Insulin Resistance
Metabolic Syndrome
Obesity
Behavioral: Low-intensity treadmill exercise
Behavioral: Moderate-intensity treadmill exercise
Behavioral: Non-aerobic stretching exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Insulin sensitivity (clamp) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aerobic fitness (VO2Max, Anaerobic threshold, endurance time) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Body mass index, waist circumference [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Fat mass, fat-free mass, lean body mass (DEXA) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Fasting lipid profile [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Apolipoprotein B [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Highly-sensitive C-reactive protein [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Exercise behavior questionnaire scores [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Any adverse events [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: October 2004
Study Completion Date: April 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687128

Locations
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
Investigators
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
  More Information

Additional Information:
No publications provided

Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00687128     History of Changes
Other Study ID Numbers: 04-10-788, U54RR014616
Study First Received: May 27, 2008
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014