Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics
研究概览
简要总结
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
- •Subjects must have Type 2 Diabetes
- •Subjects must be otherwise healthy
- •Ages of 30-60 years
- •BMI of 25-39 and stable weight for 3 months prior to the start of the study
- •Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
- •Total glycosylated hemoglobin levels (HbA1C) ≤9% (fair control) on current therapy.
排除标准
- •Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
- •Concurrent enrollment in an interventional study.
- •Any tobacco use either current or within the last year
- •Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
- •Autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded.
- •Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (> 1 mm ST segment depression) on screening exercise test.
- •Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
- •Presence of systolic blood pressure >190 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise
- •Proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of severe renal disease
- •Proliferative retinopathy
- •Insulin, incretin, or glitazone treatment
- •Niacin treatment
- •History of peptic ulcers
- •A history of hereditary angioedema
- •C1 esterase deficiency
- •Women who are pregnant or breastfeeding
- •Use of fibrate drugs
研究组 & 干预措施
Acipimox
Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi
干预措施: Acipimox (Drug)
Placebo
Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics
时间窗: 7 to 9 days
Evaluate the impact of these effects of NEFA-lowering VO2 kinetics as measured by tau2, the time required for VO2 to reach 67% of peak during submaximal exercise.
Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2
时间窗: 7 to 9 days
Evaluate the impact of these effects of NEFA-lowering on exercise capacity measured as peak VO2.
次要结局
- Triglycerides(7 to 9 days)
- Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function(7 to 9 days)
- Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Cardiac Function(7 to 9 days)
- Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise(7 to 9 days)
- Insulin Sensitivity(7 to 9 days)
- Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate(7 to 9 days)
- Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation(7 to 9 days)