Metabolic Syndrome Diagnosis and Education Trial

Mayo Clinic

Status: Completed

Conditions: Metabolic Cardiovascular Syndrome

Treatments: Other: High-Tech Education; Other: Low-Tech Education

Study type: Interventional

Funder types: Other

Identifiers

NCT00943254

07-006106

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 3 patient groups

Arm 1

Experimental group

Description:

Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials

Treatment:

Other: High-Tech Education

Arm 2

Experimental group

Description:

Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material

Treatment:

Other: Low-Tech Education

Arm 3

No Intervention group

Description:

Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material