Metabolic Syndrome Diagnosis and Education Trial

Metabolic Cardiovascular Syndrome Clinical Trial

Official title:

Metabolic Syndrome: Impact of Receiving the Diagnosis and Education Intervention on Cardiovascular Risk Factor Modification and Willingness to Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943254
• Other study ID #: 07-006106
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: October 13, 2010
• Start date: October 2007
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Cardiovascular Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lifestyle Change: Readiness to Exercise, level of physical activity		6 weeks	No
Primary	Stages of Change for Exercise and for Fruits and vegetables		6 weeks	No