Gut Permeability-related Inflammation and Cardiovascular Disease Risk in Normal-weight and Metabolically Healthy Obesity
1 other identifier
observational
80
1 country
1
Brief Summary
The investigators are examining the extent gut permeability explains observed inflammation in normal-weight and metabolically healthy obesity (and potentially cardiovascular disease risk).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2022
CompletedFirst Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedApril 15, 2022
April 1, 2022
10 months
March 11, 2022
April 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Indicators of gut permeability
The investigators will measure serum markers of gut permeability as primary outcomes (i.e., lipopolysaccharide binding protein, soluble cluster of differentiation (CD)14, intestinal fatty acid binding protein).
1 year
C-reactive protein
The investigators will measure the marker of chronic inflammation C-reactive protein (CRP) using an ELISA.
1 year
Inflammatory cytokines
The investigators will measure a panel of serum inflammatory cytokines that includes granulocyte macrophage-colony stimulating factor (GM-CSF), interferon (IFN)-γ, interleukin (IL)-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A, IL-23, and tumor necrosis factor (TNF)-α using a bioplex assay.
1 year
Secondary Outcomes (1)
Fecal microbiota
1 year
Other Outcomes (2)
Body composition assessment with dual-energy X-ray absorptiometry (DXA)
Through study completion, an average of 1 year
Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer
Through study completion, an average of 1 year
Study Arms (4)
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).
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).
Metabolically Healthy Obesity
Metabolically healthy obesity will be defined as having an obese BMI (\> 30 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).
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).
Interventions
Each participant will provide a blood and fecal sample.
Eligibility Criteria
The study populations of interest are those with normal weight obesity (normal BMI and high body fat percent) and metabolically healthy obesity (obese BMI, but largely normal cardiovascular risk factors).
You may qualify if:
- Control group: normal BMI, body fat percentage \< 25% for men and \< 35% for women, \< 1 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).
- Normal-weight obesity group: normal BMI, body fat percentage \> 25% for men and \> 35% for women.
- Metabolically healthy obesity: BMI \> 30, body fat percentage \> 25% for men and \> 35% for women, and \< 1 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).
- Metabolic syndrome group: BMI \> 30, body fat percentage \> 25% for men and \> 35% for women, 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
- Cardiometabolic disease (e.g., diabetes, cardiovascular disease)
- Disease that is inflammatory in nature (e.g., inflammatory bowel disease, rheumatoid arthritis)
- Postmenopausal status
- Use of tobacco products
- Using illicit drugs
- Using lipid lowering drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
208 Nancy Randolph Davis, Oklahoma State University
Stillwater, Oklahoma, 74078, United States
Biospecimen
The investigators are collecting serum and fecal samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2022
First Posted
April 4, 2022
Study Start
March 10, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
April 15, 2022
Record last verified: 2022-04