Back to resultsIdentification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity
Primary Purpose
Metabolic Syndrome, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-fat shake
Sponsored by
About this trial
This is an interventional screening trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- Oklahoma State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Control group
Normal-weight obesity
Metabolic Syndrome
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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.
Full Information
NCT ID
NCT05008952
First Posted
August 4, 2021
Last Updated
August 16, 2021
Sponsor
Oklahoma State University
1. Study Identification
Unique Protocol Identification Number
NCT05008952
Brief Title
Identification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity
Official Title
Postprandial Triglycerides, Endothelial Function, and Inflammatory Cytokines as Potential Candidates for Early Risk Detection in Normal-weight Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Normal-weight obesity
Arm Type
Experimental
Arm Description
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).
Arm Title
Metabolic Syndrome
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
High-fat shake
Intervention Description
All participants will be given a high-fat test meal to examine their postprandial triglyceride response.
Primary Outcome Measure Information:
Title
4-hour triglycerides after fat tolerance test
Description
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.
Time Frame
Within 2 weeks of study enrollment
Secondary Outcome Measure Information:
Title
Flow-mediated dilation
Description
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)
Time Frame
Within 2 weeks of study enrollment
Title
Fasting serum cytokines
Description
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.
Time Frame
Within 10 months of study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078-6104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Identification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity
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