Recruiting

Observational Study

Sponsor:

Oklahoma State University

Code:

NCT05308394

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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).

Conditions

Obesity

Study ID

NCT05308394

Start date

Mar 10, 2022

Status verified date

Apr, 2022

Completion date

Dec 30, 2022

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Indicators of gut permeability [ Time Frame: 1 year ]
  • C-reactive protein [ Time Frame: 1 year ]
  • Inflammatory cytokines [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

208 Nancy Randolph Davis, Oklahoma State University

Recruiting

Stillwater, Oklahoma, United States, 74078

Contacts

Bryant H Keirns, MS

316-689-1711bryant.keirns@okstate.edu

More Information

Sponsor

Oklahoma State University

Last update posted

Apr 15, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oklahoma State University on 2022-04-15.