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

Study Overview
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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.

Official Title
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Postprandial Triglycerides, Endothelial Function, and Inflammatory Cytokines as Potential Candidates for Early Risk Detection in Normal-weight Obesity

Conditions
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Metabolic Syndrome, Obesity

Intervention / Treatment
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* Other: High-fat shake


Participation Criteria
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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). Exclusion Criteria: Presence of pacemaker Pregnant use of tobacco products using lipid lowering drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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). | Other: High-fat shake<br>* All participants will be given a high-fat test meal to examine their postprandial triglyceride response.<br>|
| Experimental: Normal-weight obesity<br>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). | Other: High-fat shake<br>* All participants will be given a high-fat test meal to examine their postprandial triglyceride response.<br>|
| Active Comparator: Metabolic Syndrome<br>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). | Other: High-fat shake<br>* All participants will be given a high-fat test meal to examine their postprandial triglyceride response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-hour triglycerides after fat tolerance test | Participants will undergo an abbreviated fat tolerance test, where fasting triglycerides are measured, a high-fat shake is consumed, and triglycerides measured once more 4 hours later. 4 hour triglycerides after the high-fat meal is our primary outcome. | Within 2 weeks of study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation | Flow-mediated dilation is a non-invasive technique to investigate vascular health. This technique will be performed when participants are fasting and  4 hours after the shake is completed (just before final measurement of triglycerides) | Within 2 weeks of study enrollment | 
| Fasting serum cytokines | A number of cytokines including GM-CSF, IFN-gamma, IL-1beta, IL-2, IL-5, IL-6, IL-8, IL-12p70, IL-13, IL-17, TNF-alpha, IL-4, IL-10 will be measured as additional cardiovascular disease risk factors. | Within 10 months of study enrollment |