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Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome - Article


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Counseling And Guidance




Clinical Trial: Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome

This study is currently recruiting patients.
Verified by National Center for Complementary and Alternative Medicine (NCCAM) August 2005

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00129792

Purpose

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.
Condition Intervention
Metabolic Syndrome X
Prediabetic State
Insulin Resistance
Obesity
Metabolic Diseases
 Drug: Dietary supplement for weight loss
 Behavior: Education and counseling for weight loss

MedlinePlus related topics:  Diabetes;   Metabolic Disorders;   Metabolic Syndrome X;   Obesity

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome

Further Study Details: 
Primary Outcomes: Cholesterol; insulin function; weight loss
Secondary Outcomes: Cortisol levels
Expected Total Enrollment:  100

Study start: July 2005

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 and diabetes. The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.

This study will last 12 weeks. Participants will be randomly assigned to one of three arms. Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50% chance of receiving either the supplement or placebo; participants in Arm 3 will receive placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after the follow-up visit. Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin, cholesterol, and levels of certain hormones. Participants will also be asked to complete questionnaires at study entry and at Week 12; the questionnaires will assess depression, stress, self-absorption, optimism, food cravings, hunger, the degree to which participants seek pleasure from activities, and participants'''' thoughts about their ability to make behavioral changes.

Eligibility

Ages Eligible for Study:  21 Years   -   60 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 30 and 40
  • 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 110 mg/dl or higher

Exclusion Criteria:

  • 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129792

Margaret Warman, MPhil, MEd      503-552-1749    mwarman@ncnm.edu

Oregon
      Oregon Health and Science University General Clinical Research Center, Portland,  Oregon,  97239,  United States; Recruiting
Margaret Warman, MPhil, MEd  503-552-1749    mwarman@ncnm.edu 
Jon Purnell, MD,  Sub-Investigator

Study chairs or principal investigators

Carlo Calabrese, ND, MPH,  Principal Investigator,  Helfgott Research Institute at the National College of Naturopathic Medicine   

More Information

Study ID Numbers:  U19 AT002656-02
Last Updated:  August 11, 2005
Record first received:  August 10, 2005
ClinicalTrials.gov Identifier:  NCT00129792
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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December 4, 2008



Page Updated: November 5, 2004
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