Identification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-07-20

Brief Summary

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The purpose of this study is to identify early cardiovascular disease risk factors in those with "normal-weight obesity" (i.e., normal body, but high body fat percentage) that better track with their long-term cardiovascular disease risk.

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Detailed Description

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Conditions

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Metabolic Syndrome Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 study groups: control (normal body mass index, low body fat percentage), normal-weight obesity ((normal body mass index, high body fat percentage), and metabolic syndrome

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control group

The control group for this study will consist of individuals with normal BMI (18.5 - 24.9 kg/m2), body fat percent \< 25% (male) or \< 35% (female), and up to 1 other risk factor among the following: blood pressure \> 130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, and HDL \< 40 (male) or \< 50 (female).

Group Type ACTIVE_COMPARATOR

High-fat shake

Intervention Type OTHER

All participants will be given a high-fat test meal to examine their postprandial triglyceride response.

Normal-weight obesity

Individuals with normal-weight obesity will be defined as having normal BMI (18.5 - 24.9 kg/m2), body fat percent \> 25% (male) or \> 35% (female).

Group Type EXPERIMENTAL

High-fat shake

Intervention Type OTHER

All participants will be given a high-fat test meal to examine their postprandial triglyceride response.

Metabolic Syndrome

Metabolic syndrome will be defined using the international Diabetes Federation criteria of an obese BMI ( \> 30 kg/m2) and 2 or more of the following risk factors: blood pressure \> 130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, and HDL \< 40 (male) or \< 50 (female).

Group Type ACTIVE_COMPARATOR

High-fat shake

Intervention Type OTHER

All participants will be given a high-fat test meal to examine their postprandial triglyceride response.

Interventions

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High-fat shake

All participants will be given a high-fat test meal to examine their postprandial triglyceride response.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Control group: normal BMI, body fat percentage \< 25% for men and 35% for women

Normal-weight obesity group: normal BMI, body fat percentage \> 25% for men and 35% for women

Metabolic syndrome group: BMI \> 30 and 2 or more of the following: blood pressure \>130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).