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Metabolic Syndrome Diagnosis and Education Trial

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00943254
First received: July 20, 2009
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention
Metabolic Cardiovascular Syndrome
 Other: High-Tech Education
Other: Low-Tech Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Lifestyle Change: Readiness to Exercise, level of physical activity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Stages of Change for Exercise and for Fruits and vegetables [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943254

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

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Randal J Thomas, MD, Mayo Clinic- Rohester
ClinicalTrials.gov Identifier: NCT00943254     History of Changes
Other Study ID Numbers: 07-006106
Study First Received: July 20, 2009
Last Updated: October 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Metabolic Cardiovascular Syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013