Investigating microvascular dysfunction in obese individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the relationship between obesity and endothelial dysfunction, focusing on the role of reactive oxygen species (ROS) and the enzyme NADPH-oxidase. It aims to assess the effects of exercise on microvascular endothelial function in sedentary individuals with class 2 obesity and metabolic syndrome. Participants will include premenopausal women on hormonal contraceptives and men and women aged 18-45 with specific obesity-related health criteria. The study will measure changes in ROS levels and endothelial function following exercise interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* There will be no restrictions with regard to race, sex, or socioeconomic status.
* Women will be premenopausal
* Women will be on combined estrogen/progestin hormonal contraceptive therapy (oral pill, transdermal patch or vaginal ring).
* Sedentary obese individuals will have been weight stable for the preceding 6 months.
* Sedentary obese individuals will have the Metabolic Syndrome as defined according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).
* Individuals with the Metabolic Syndrome will have at least three of the following:

  1. Central obesity as measured by waist circumference (men \>40 inches; women \>35 inches);
  2. Fasting blood triglycerides \> 150 mg/dL;
  3. Blood HDL cholesterol in men\<40 mg/dL and women \<50 mg/dL;
  4. Blood pressure \> 130/85 mmHg; 5) Fasting blood glucose \> 110 mg/dL, and (not per ATP III) a 2-hour GTT glucose of 140-200 mg/dl.

Exclusion Criteria:

* Subjects participating in purposeful endurance exercise training (\>20 min/day, \>1 day/week) will be excluded.
* Pre-menopausal female subjects must not be pregnant or lactating, and must have had regular menstrual cycles for the past year.
* Individuals taking medications that may affect central or peripheral circulation,
* Individuals on nonsteroidal anti-inflammatory agents or serotonin reuptake inhibitors,
* Individuals who smoke or chew tobacco,
* Individuals with diabetes (fasting blood glucose \>125 mg/dL),
* hypertension \>160/95 mmHg
* Individuals with congestive heart failure, angina, or peripheral vascular disease. --Individuals with ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected in ST-segment depression of 1 mm or greater at rest or during exercise.
* Individuals with chronic infections, paralysis due to stroke, advanced Parkinson's Disease, severe rheumatoid arthritis or other serious orthopedic problems that would prevent performance of the exercise training tasks will be excluded.
* Individuals taking antioxidant, herbal or vitamin supplementation for at least 2 weeks prior to investigation.
* Individuals ingesting caffeine the day of the experiment.
* Individuals whose weight changes by more than 5% during the training program.
* Individuals whose exercise adherence is below 90% of the exercise sessions or total exercise time.

Where it's running

• Florida State University
  Tallahassee, Florida, United States Recruiting

Study contacts

• Principal investigator: Robert C Hickner, PhD — Florida State University
• Study coordinator: Robert C Hickner, PhD
• Email: rhickner@fsu.edu
• Phone: 850-644-1375

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.