Exercise Dose and Metformin for Vascular Health in Adults With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in Fasting Unscaled Flow Mediated Dilation (FMD) of the Brachial Artery
研究概览
简要总结
Health organizations recommend exercise in an intensity based manner to promote cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication that reduces future type 2 diabetes and cardiovascular disease (CVD) risk. However, the optimal dose of exercise to be combined with metformin for vascular health remains unknown. The purpose of this study is to evaluate whether combining high or low intensity exercise with metformin has the potential to outperform either exercise intensity alone on blood flow across the arterial tree as well as impact insulin action in individuals with metabolic syndrome. Identification of such outcomes will indicate 1) whether and how metformin should be combined with physical activity for CVD prevention, 2) provide the first indication of whether exercise intensity reduces CVD risk via multi-level vasculature function vs. metabolic insulin action, and 3) provide a rational early treatment for people with metabolic syndrome to prevent/treat type 2 diabetes and CVD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥40 and ≤80 years old.
- •Has a body mass index ≥25 and ≤47 kg/m
- •Not diagnosed with Type 2 or Type 1 diabetes
- •Not currently engaged in > 150 min/wk of exercise
- •Weight stable (<2kg weight change in past 3 months)
- •Non-smoking >5 years
- •At minimum, subject 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 (<40mg/dl in men, <50 mg/dl in women), or on medication for treating the condition
- •High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic), or on medication for treating the condition
- •Elevated fasting glucose (≥100 mg/dl), or on medication for treating the condition
- •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
- •Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers)
排除标准
- •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)
- •Subjects who are considered non-English speaking individuals
研究组 & 干预措施
LoEx with Placebo
Low intensity exercise with placebo.
干预措施: Placebo (Drug)
LoEx with Placebo
Low intensity exercise with placebo.
干预措施: Low Intensity Exercise (Behavioral)
HiEx with Placebo
High intensity exercise with placebo.
干预措施: Placebo (Drug)
HiEx with Placebo
High intensity exercise with placebo.
干预措施: High Intensity Exercise (Behavioral)
LoEx with Metformin
Low intensity exercise with metformin.
干预措施: Metformin (Drug)
LoEx with Metformin
Low intensity exercise with metformin.
干预措施: Low Intensity Exercise (Behavioral)
HiEx with Metformin
High intensity exercise with metformin.
干预措施: Metformin (Drug)
HiEx with Metformin
High intensity exercise with metformin.
干预措施: High Intensity Exercise (Behavioral)
结局指标
主要结局
Change in Fasting Unscaled Flow Mediated Dilation (FMD) of the Brachial Artery
时间窗: 0 and 16 weeks
Endothelial function assessed as a percentage change in brachial artery diameter from baseline to deflation (5 minutes after artery occlusion by blood pressure cuff inflation). Delta = Week 16 - Week 0. Higher values and positive change scores following the intervention indicate a better outcome.
次要结局
- Change in Metabolic Insulin Sensitivity. Glucose Infusion Rate Normalized to Steady-State Insulin (GIR).(0 and 16 weeks)
- Change in Fasting Augmentation Index(0 and 16 weeks)
- Change in Insulin-stimulated Microvascular Blood Flow (MBF) of the Forearm.(0 and 16 weeks)
- Change in Insulin-stimulated Microvascular Flow Velocity (MFV) of the Forearm.(0 and 16 weeks)
- Change in Insulin-stimulated Microvascular Blood Volume (MBV) of the Forearm.(0 and 16 weeks)
研究者
Steven K Malin, PhD
Principal Investigator
Rutgers University