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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008952
• Other study ID #: IRB-20-339-STW
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 20, 2021

Study information

• Verified date: August 2021
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

Other:
• High-fat shake
All participants will be given a high-fat test meal to examine their postprandial triglyceride response.

Locations

Country	Name	City	State
United States	Oklahoma State University	Stillwater	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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