Exercise Dose-Response on Features of the Metabolic Syndrome

NCT00687128 | Completed DMC

• 2 other identifiers: 04-10-788U54RR014616
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Metabolic Syndrome; Obesity

Keywords

Insulin resistance; Metabolic syndrome; Aerobic exercise; Exercise behavior

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity (clamp)

  6 months

Secondary Outcomes (10)

• Aerobic fitness (VO2Max, Anaerobic threshold, endurance time)

  6 and 12 months

• Body mass index, waist circumference

  6 and 12 months

• Fat mass, fat-free mass, lean body mass (DEXA)

  6 and 12 months

• Blood pressure

  6 and 12 months

• Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index

  6 and 12 months

Study Arms (3)

1

EXPERIMENTAL

Low-intensity aerobic exercise

Behavioral: Low-intensity treadmill exercise

2

EXPERIMENTAL

Moderate-intensity aerobic exercise

Behavioral: Moderate-intensity treadmill exercise

3

ACTIVE COMPARATOR

Non-aerobic stretching exercise

Behavioral: Non-aerobic stretching exercise

Interventions

Low-intensity treadmill exercise BEHAVIORAL

Treadmill walking at 30% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.

Also known as: "Casual" walking program

1

Moderate-intensity treadmill exercise BEHAVIORAL

Treadmill walking at 60% of VO2Reserve, 3-5 times per week at 20-60 minutes per session, progressive.

Also known as: "Brisk" walking program

2

Non-aerobic stretching exercise BEHAVIORAL

Floor stretching exercise, 3-5 times per week at 20-60 minutes duration per session, progressive.

Also known as: Non-aerobic control

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Related Links

• 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

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanley Hsia, MD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: October 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: April 1, 2010
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (1)