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Search / Trial NCT04087655

Microvascular Dysfunction in Obesity

Launched by FLORIDA STATE UNIVERSITY · Sep 10, 2019

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how exercise affects blood vessel function in people who are obese. It specifically looks at a process called oxidative stress, which can harm blood vessels and lead to health problems like heart disease and diabetes. Researchers want to understand how an 8-week aerobic exercise program can improve blood vessel function by reducing harmful substances in the body. They will use a special technique to monitor these changes in the muscles of participants during the study.

To be eligible for this trial, participants should be sedentary, obese individuals aged 65 to 74, and must have certain health conditions related to obesity, known as Metabolic Syndrome. This includes having a larger waist size, high blood pressure, and elevated blood sugar or cholesterol levels. Women participating must be premenopausal and on specific hormonal birth control methods. Participants can expect to engage in an exercise program while undergoing tests to monitor their health changes. It's important to note that individuals with certain health issues, such as diabetes or heart conditions, will be excluded from the trial for safety reasons.

Gender

ALL

Eligibility criteria

  • 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.

About Florida State University

Florida State University (FSU) is a prestigious public research institution located in Tallahassee, Florida, known for its commitment to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, FSU leverages its extensive academic resources and expertise to conduct rigorous research aimed at improving patient outcomes and contributing to the medical community. The university fosters a collaborative environment that brings together multidisciplinary teams to design, implement, and analyze clinical studies, ensuring adherence to the highest ethical and scientific standards. Through its clinical trials, FSU aims to address critical health challenges and translate research findings into practical applications that benefit society.

Locations

Tallahassee, Florida, United States

Patients applied

0 patients applied

Trial Officials

Robert C Hickner, PhD

Principal Investigator

Florida State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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