Clinical trial NCT00687128: Exercise Dose-Response on Features of the Metabolic Syndrome
Official title: Dose-Response Effects of Aerobic Exercise on Insulin Sensitivity and the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Metabolic Syndrome
Obesity
Keywords: Insulin resistance
Metabolic syndrome
Aerobic exercise
Exercise behavior
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-05-30
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Insulin sensitivity (clamp)
timeFrame: 6 months
Secondary outcomes:
measure: Aerobic fitness (VO2Max, Anaerobic threshold, endurance time)
timeFrame: 6 and 12 months
measure: Body mass index, waist circumference
timeFrame: 6 and 12 months
measure: Fat mass, fat-free mass, lean body mass (DEXA)
timeFrame: 6 and 12 months
measure: Blood pressure
timeFrame: 6 and 12 months
measure: Fasting glucose, hemoglobin A1c, glucose 2 hours post-oral glucose tolerance test, HOMA-IR index
timeFrame: 6 and 12 months
measure: Fasting lipid profile
timeFrame: 6 and 12 months
measure: Apolipoprotein B
timeFrame: 6 and 12 months
measure: Highly-sensitive C-reactive protein
timeFrame: 6 and 12 months
measure: Exercise behavior questionnaire scores
timeFrame: 6 and 12 months
measure: Any adverse events
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Stanley Hsia, MD
role: PRINCIPAL_INVESTIGATOR
References: