Exercise Dose and Metformin for Vascular Health in Adults With Metabolic Syndrome

Launched by · Mar 23, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how different amounts of exercise, combined with the medication metformin, can improve blood vessel health in adults with metabolic syndrome. Metabolic syndrome is a condition that increases the risk of heart disease and diabetes. The researchers want to find out if low-intensity exercise combined with metformin is more effective for improving blood vessel function compared to high-intensity exercise with metformin or exercise without the medication. Over the course of 16 weeks, participants will be randomly assigned to one of four groups: low-intensity exercise with a placebo, low-intensity exercise with metformin, high-intensity exercise with a placebo, or high-intensity exercise with metformin.

To participate in this trial, you must be between 40 and 80 years old, have a body mass index (BMI) between 25 and 47, and not currently have type 2 diabetes. You should also not be exercising regularly (more than 150 minutes a week) and must have some characteristics of metabolic syndrome, such as excess belly fat or high blood pressure. If you decide to join, you can expect to engage in a structured exercise program while receiving either metformin or a placebo. This study is currently recruiting participants, and your involvement could help researchers learn more about how to improve vascular health in people with metabolic syndrome.

Gender

All

Eligibility criteria

• Inclusion Criteria:
• • Male or female ≥ 40 and ≤ 80 years old
• • Has a body mass index ≥ 25 and ≤ 47 kg/m^2
• • Not diagnosed with Type 2 diabetes
• • Not currently engaged in > 150 min/wk of exercise
• At minimum, subjects will have abdominal obesity (increased waist circumference as defined below) and may have any additional National Cholesterol Education Adult Treatment Panel III Metabolic Syndrome criteria:
• • Increased waist circumference (≥ 102 cm in men; ≥ 88 cm in women)
• • Elevated triglycerides (≥ 150 mg/dl), or on medication for treating the condition
• • Reduced HDL-cholesterol (< 40 mg/dl in men, < 50 mg/dl in women), or on medication for treating the condition
• • High blood pressure (≥ 130 mmHg systolic or ≥ 85 mmHg diastolic), or on medication for treating the condition
• • Elevated fasting glucose (≥ 100 mg/dl), or on medication for treating the condition
• • Subjects currently taking medications that affect heart rate and rhythm (i.e. calcium-channel blockers, nitrates, alpha- or beta-blockers)
• Other major risk factors to be noted based on the Framingham Risk Score:
• • HbA1c 5.7-6.4%
• • LDL > 130 mg/dL
• • Family history of type 2 diabetes (immediate family, i.e. parent/sibling)
• • History of gestational diabetes
• • History of Polycystic Ovarian Syndrome
• • Family history of pre-mature cardiovascular disease (immediate family i.e. parent/sibling) before 55 for males or 65 for females that can include heart attack, peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease or clinical coronary heart disease)
• • Age ( > 45 years old for men; > 55 years old for women)
• • Black/African American, Mexican, Asian, and/or Hispanic
• Exclusion Criteria:
• • Morbidly obese patients (BMI > 47 kg/m^2) and overweight/lean patients (BMI < 27 kg/m^2)
• • Evidence of type 1 diabetes and diabetics requiring insulin therapy
• • Subjects who have not been weight stable (> 2 kg weight change in past 3 months)
• • Subjects who have not been recently active (> 30 min of moderate/high intensity exercise, 2 times/week)
• • Subjects who are smokers or who have quit smoking < 5 years ago
• • Subjects prescribed metformin or have taken metformin within 1 year
• • Subjects with abnormal estimated glomerular filtration rate (eGFR)
• • Hypertriglyceridemic (> 400 mg/dl) and hypercholesterolemic (> 260 mg/dl) subjects
• • Hypertensive ( > 160/100 mmHg)
• • Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety
• • Pregnant (as evidenced by positive pregnancy test) or nursing women
• • Subjects with contraindications to participation in an exercise training program
• • Currently taking active weight suppression medication (e.g. phentermine, orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)
• • Known hypersensitivity to perflutren (contained in Definity microbubbles)
• • Subjects who are considered non-English speaking individuals