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

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Other: High-fat shake

• Registration Number: NCT05008952
• Lead Sponsor: Oklahoma State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-20
• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

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Exclusion Criteria

• Presence of pacemaker
• Pregnant
• use of tobacco products
• using lipid lowering drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal-weight obesity	High-fat shake	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).
Control group	High-fat shake	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).
Metabolic Syndrome	High-fat shake	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).

Primary Outcome Measures

Name	Time	Method
4-hour triglycerides after fat tolerance test	Within 2 weeks of study enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Fasting serum cytokines	Within 10 months of study enrollment	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.
Flow-mediated dilation	Within 2 weeks of study enrollment	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)

Trial Locations

Locations (1)

Oklahoma State University; 🇺🇸 Stillwater, Oklahoma, United States