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

NCT05008952 | Completed

• 1 other identifier: IRB-20-339-STW
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Flow-mediated dilation

  Within 2 weeks of study enrollment

• Fasting serum cytokines

  Within 10 months of study enrollment

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Normal-weight obesity

EXPERIMENTAL

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

Metabolic Syndrome

ACTIVE COMPARATOR

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

Interventions

High-fat shake OTHER

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

Control group; Metabolic Syndrome; Normal-weight obesity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078-6104, United States

Location

Related Publications (1)

• Hart SM, Keirns BH, Sciarrillo CM, Malin SK, Kurti SP, Emerson SR. Cardiorespiratory fitness and submaximal exercise dynamics in normal-weight obesity and metabolically healthy obesity. Eur J Appl Physiol. 2024 Apr;124(4):1131-1142. doi: 10.1007/s00421-023-05344-8. Epub 2023 Nov 2.

  PMID: 37917417 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 17, 2021
• Study Start: September 1, 2020
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)