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OpenTrials
Completed

NCT Number: NCT05008952

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

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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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University

Stillwater, Oklahoma, 74078-6104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-fat shake

Other

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

Primary outcomes

  1. 4-hour triglycerides after fat tolerance test

    Time frame: 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 outcomes

  1. Flow-mediated dilation

    Time frame: 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)

  2. Fasting serum cytokines

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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