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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Other: High-fat shake

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078-6104
      • Oklahoma State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; All participants will be given a high-fat test meal to examine their postprandial triglyceride response.
Experimental: Normal-weight obesity; 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; All participants will be given a high-fat test meal to examine their postprandial triglyceride response.
Active Comparator: Metabolic Syndrome; 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; All participants will be given a high-fat test meal to examine their postprandial triglyceride response.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome
• Other Study ID Numbers: IRB-20-339-STW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No