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Metabolic Syndrome Diagnosis and Education Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943254
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : October 15, 2010
Information provided by:
Mayo Clinic

Brief Summary:
This study is being done to gain knowledge on how effective different approaches of providing a diagnosis and varying educational tools that include DVDs and multimedia or printed instruction sheets on your readiness to increase the subject's level of exercise, lose more weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart disease and their readiness to participate in a comprehensive lifestyle modification program.

Condition or disease Intervention/treatment Phase
Metabolic Cardiovascular Syndrome Other: High-Tech Education Other: Low-Tech Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change
Study Start Date : October 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials
Other: High-Tech Education
Patients will be told that they have the metabolic syndrome and will subsequently watch two 10-minute videos on the metabolic syndrome and on getting started with exercise. They also receive all the paper-based educational material as in arm 2

Experimental: Arm 2
Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material
Other: Low-Tech Education
Patients will be told that they have the metabolic syndrome and will subsequently receive paper-based educational material on the metabolic syndrome,pre-diabetes, and hypertension. They also receive pamphlets on dietary management of high cholesterol and triglycerides, and the importance of exercise and weight loss.

No Intervention: Arm 3
Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material

Primary Outcome Measures :
  1. Lifestyle Change: Readiness to Exercise, level of physical activity [ Time Frame: 6 weeks ]
  2. Stages of Change for Exercise and for Fruits and vegetables [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Any 3 of the following 5:

  1. History of hypertension or either systolic blood pressure >125 or diastolic blood pressure >85 mmHg or documented history and receiving treatment for it
  2. Abdominal circumference ≥40 inches in men or ≥35 inches in women
  3. Fasting triglycerides ≥ 150mg/dL or receiving treatment for it
  4. Fasting blood glucose ≥ 100mg/dL but <126mg/dL
  5. HDL cholesterol <40mg/dL in men or <50mg/dL in women or receiving treatment for it

Exclusion Criteria:

  1. Documented diagnosis of metabolic syndrome in the clinical record, if previously seen at Mayo.
  2. History of coronary artery disease
  3. Diabetes mellitus, or using an oral hypoglycemic pill for glucose intolerance
  4. Congestive heart failure
  5. Familial hypercholesterolemia including familial hypertriglyceridemia,
  6. Fasting LDL-cholesterol >160 mg/dL
  7. Fasting triglycerides > 390 mg/dL
  8. Have systolic blood pressure >160 and diastolic blood pressure >100mg/dL
  9. History of hypertension with changes in their blood pressure medicines within the last 60 days before enrollment.
  10. History of dyslipidemia and changes on their lipid lowering agents such as statins, ezetimibe, fibrates or niacin within the last 60 days before enrollment.
  11. Secondary causes of obesity such as hypothyroidism, Cushing syndrome, or eating disorders
  12. Pregnant women or women planning to get pregnant during the duration of the study
  13. Advanced liver disease
  14. Renal insufficiency
  15. Having any other major chronic medical condition
  16. Unable to do their basic chores at home due to musculoskeletal limitations or other factors affecting their functional status.
  17. Physical activity of more than 60 minutes per week of moderate to intense exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00943254

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Randal J Thomas, MD, MS Mayo Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Randal J Thomas, MD, Mayo Clinic- Rohester Identifier: NCT00943254    
Other Study ID Numbers: 07-006106
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010
Keywords provided by Mayo Clinic:
Metabolic Cardiovascular Syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases