Exercise Dose-Response on Features of the Metabolic Syndrome
This study has been completed.
Sponsor:
Charles Drew University of Medicine and Science
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
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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:
MedlinePlus related topics:
Diabetes Medicines
Exercise and Physical Fitness
Metabolic Syndrome
Obesity
U.S. FDA Resources
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 May 19, 2013