Status:
RECRUITING
Microvascular Dysfunction in Obesity
Lead Sponsor:
Florida State University
Conditions:
Obesity
Endothelial Dysfunction
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Impaired endothelial function is observed in disease states related to obesity, such as atherosclerosis, coronary artery disease, and diabetes. Reactive oxygen species (ROS) production and resultant o...
Detailed Description
Twenty-five sedentary class 2 and above obese \[body mass index (BMI) \>35 kg/m2, waist circumference \>40 inches (men) or \>35 inches (women)\] men and women (18-45 yrs) will participate in these exp...
Eligibility Criteria
Inclusion
- 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:
- Central obesity as measured by waist circumference (men \>40 inches; women \>35 inches);
- Fasting blood triglycerides \> 150 mg/dL;
- Blood HDL cholesterol in men\<40 mg/dL and women \<50 mg/dL;
- 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
- 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.
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04087655
Start Date
November 20 2019
End Date
May 31 2027
Last Update
December 11 2025
Active Locations (1)
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1
Florida State University
Tallahassee, Florida, United States, 32306