Obesity Clinical Trial
Official title:
Gut Permeability-related Inflammation and Cardiovascular Disease Risk in Normal-weight and Metabolically Healthy Obesity
NCT number | NCT05308394 |
Other study ID # | IRB-22-28 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 10, 2022 |
Est. completion date | December 30, 2022 |
Verified date | April 2022 |
Source | Oklahoma State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators are examining the extent gut permeability explains observed inflammation in normal-weight and metabolically healthy obesity (and potentially cardiovascular disease risk).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | 208 Nancy Randolph Davis, Oklahoma State University | Stillwater | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Oklahoma State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body composition assessment with dual-energy X-ray absorptiometry (DXA) | The investigators will perform DXA scans on all participants to assess body composition parameters (i.e., body fat percent, lean mass, percent, visceral adipose tissue). | Through study completion, an average of 1 year | |
Other | Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer | The investigators will perform a lipid panel on all participants. | Through study completion, an average of 1 year | |
Primary | 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 | |
Primary | C-reactive protein | The investigators will measure the marker of chronic inflammation C-reactive protein (CRP) using an ELISA. | 1 year | |
Primary | Inflammatory cytokines | The investigators will measure a panel of serum inflammatory cytokines that includes granulocyte macrophage-colony stimulating factor (GM-CSF), interferon (IFN)-?, interleukin (IL)-1ß, 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)-a using a bioplex assay. | 1 year | |
Secondary | Fecal microbiota | The investigators will assess microbiota composition in a subset of individuals (~n=10 per group). | 1 year |
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