Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2021-12-31

Brief Summary

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Intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the Cardiometabolic Health Alliance. Thus there has been a call to establish new care models that assist Metabolic Syndrome patients in reducing there risk. The investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.

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Detailed Description

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Conditions

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Metabolic Syndrome ASCVD Lifestyle Risk Reduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Observation

lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Group Type OTHER

lifestyle modification

Intervention Type OTHER

nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Interventions

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lifestyle modification

nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Metabolic syndrome patients meeting 3 of 5 criteria:

1. waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women;
2. triglycerides ≥150 mg/dl;
3. high-density lipoprotein cholesterol (HDL-C) \<40 mg/dl in men and \<50 mg/dl in women;
4. blood pressure ≥130/85 mm Hg
5. fasting glucose ≥100 mg/d or HgbA1c ≥ 5.71 (includes diabetics)
* Patients requiring secondary ASCD prevention

Exclusion Criteria

* Patients with less than 5 year survival
* Patients with cancer undergoing therapy or on palliative treatment
* Patients with end stage heart failure

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No