Status:
COMPLETED
Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Metabolic Syndrome X
Prediabetic State
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
This study will determine the effects of a supplement in reducing symptoms of metabolic syndrome, a collection of symptoms that increase the risk for developing heart disease, stroke, and diabetes.
Detailed Description
Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity; these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease a...
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 30 and 45
- Live in the Portland, Oregon metropolitan area
- Willing and able to complete a 12-week weight loss program
- Meet at least 3 of the following 5 criteria: 1) waist circumference greater than 40 inches for men and 35 inches for women; 2) fasting triglycerides higher than 150 mg/dl; 3) high density lipoprotein (HDL) lower than 40 mg/dl for men and 50 mg/dl for women; 4) systolic blood pressure (BP) of 130 mmHg or higher or diastolic BP of 85 mmHg or higher; 5) fasting glucose of 100 mg/dl or higher
Exclusion
- Any medications, including dietary supplements, that could interfere with the study
- Medical conditions contraindicating a diet and exercise weight loss program
- History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic cardiovascular disease
- Current diagnosis of cancer
- Hospitalization for a psychiatric condition within 12 months prior to study entry
- Weight loss medications within 6 months prior to study entry
- Change in body weight greater than 5% within 6 months prior to study entry
- Consumption of more than 21 alcoholic drinks per week
- Current participation in another clinical trial OR living in the same household with another participant in this study
- Currently exercising for more than 30 minutes, 3 times per week
- Fasting blood glucose higher than 125 mg/dl
- BP higher than 145/90
- Triglycerides higher than 500 mg/dl
- Training as a health care provider or health scientist
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00129792
Start Date
January 1 2005
End Date
April 1 2014
Last Update
October 29 2014
Active Locations (1)
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1
Oregon Health and Science University General Clinical Research Center
Portland, Oregon, United States, 97239