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

NCT ID: NCT05308394

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-12-30

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.

Conditions

Obesity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

No experimental intervention will take place - the study is cross-sectional. Each participant will provide biological samples.

Intervention Type: OTHER

Each participant will provide a blood and fecal sample.

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).

No experimental intervention will take place - the study is cross-sectional. Each participant will provide biological samples.

Intervention Type: OTHER

Each participant will provide a blood and fecal sample.

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).

No experimental intervention will take place - the study is cross-sectional. Each participant will provide biological samples.

Intervention Type: OTHER

Each participant will provide a blood and fecal sample.

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).

No experimental intervention will take place - the study is cross-sectional. Each participant will provide biological samples.

Intervention Type: OTHER

Each participant will provide a blood and fecal sample.

Interventions

No 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oklahoma State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

208 Nancy Randolph Davis, Oklahoma State University

Stillwater, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Bryant H Keirns, MS

Role: primary

bryant.keirns@okstate.edu

316-689-1711

Other Identifiers

IRB-22-28

Identifier Type: -

Identifier Source: org_study_id