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Gut Permeability-related Inflammation and Cardiovascular Disease Risk in Normal-weight and Metabolically Healthy Obesity

Gut Permeability-related Inflammation and Cardiovascular Disease Risk in Normal-weight and Metabolically Healthy Obesity

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05308394
Enrollment
80
Registered
2022-04-04
Start date
2022-03-10
Completion date
2022-12-30
Last updated
2022-04-15

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

Conditions

Obesity

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).

Detailed description

Cardiovascular disease (CVD) is responsible for 25% of deaths in the United States, and chronic inflammation contributes to risk. A growing body of evidence suggests that gut-derived bacterial components (e.g., lipopolysaccharide or LPS) entering the bloodstream when the gut barrier fails (i.e., intestinal permeability) are a prominent source of inflammation in cardiometabolic conditions such as metabolic syndrome, coronary artery disease, and type 2 diabetes. Two groups that are at \> 2x the risk for CVD, but largely still free of overt disease, are those with metabolically healthy obesity and normal-weight obesity. Those with metabolically healthy obesity - defined as having an obese body mass index (BMI) but other clinical risk factors in the normal range (e.g., blood lipids) - and normal-weight obesity - defined as having a normal BMI yet high percent body fat - generally display little evidence of clinical risk, but present with elevated inflammatory markers including C-reactive protein (CRP), tumor necrosis factor (TNF)-a, and interleukin (IL)-6). Therefore, it is likely that chronic inflammation is largely driving CVD risk in metabolically healthy and normal-weight obesity, but the source of this inflammation remains unclear. The primary aim of the proposed project is to determine the extent that markers of intestinal permeability are elevated in metabolically healthy obesity and normal-weight obesity compared to healthy controls and individuals with metabolic syndrome.

Interventions

OTHERNo experimental intervention will take place - the study is cross-sectional. Each participant will provide biological samples.

Each participant will provide a blood and fecal sample.

Sponsors

Oklahoma State University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years

Inclusion criteria

* 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).

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Indicators of gut permeability1 yearThe 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).
C-reactive protein1 yearThe investigators will measure the marker of chronic inflammation C-reactive protein (CRP) using an ELISA.
Inflammatory cytokines1 yearThe 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.

Secondary

MeasureTime frameDescription
Fecal microbiota1 yearThe investigators will assess microbiota composition in a subset of individuals (\ n=10 per group).

Other

MeasureTime frameDescription
Body composition assessment with dual-energy X-ray absorptiometry (DXA)Through study completion, an average of 1 yearThe investigators will perform DXA scans on all participants to assess body composition parameters (i.e., body fat percent, lean mass, percent, visceral adipose tissue).
Lipid panel with Abbott Piccolo Xpress Clinical Chemistry AnalyzerThrough study completion, an average of 1 yearThe investigators will perform a lipid panel on all participants.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026