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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05008952

Enrollment

Registered

2021-08-17

Start date

2020-09-01

Completion date

2021-07-20

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity

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.

Interventions

OTHERHigh-fat shake

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026