Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C (HbA1C)
研究概览
简要总结
Insulin resistance and hyperglycemia predispose individuals with type 2 diabetes mellitus (T2DM) to endothelial dysfunction and a greater risk of cardiovascular diseases (CVD). Increased CVD risk in individuals with T2DM persists despite optimal pharmacological therapy, highlighting the need to identify complementary lifestyle interventions that improve cardiometabolic functions in this population. Evidence from animal models suggests that heat exposure improves metabolic functions. Notably, weekly heat exposure for 16 weeks blunts hyperinsulinemia and hyperglycemia induced by a high fat diet in mice. In parallel, studies in humans have shown that heat exposure improves vascular endothelial function. Based on such findings, it has been suggested that heat therapy may represent an effective lifestyle intervention to improve cardiometabolic functions. However, only 1 study has examined the impact of a heat therapy intervention on individuals with T2DM, demonstrating that 6 weeks of heat exposure reduces fasting plasma glucose and hemoglobin A1C. No study has considered potential vascular benefits of heat therapy in individuals with T2DM.
This project will investigate cardiometabolic responses to repeated heat exposure in men and women with T2DM. We will test the hypothesis that 12 weeks of heat therapy improves postprandial fatty acid handling, insulin sensitivity and endothelial function in individuals with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-75 years
- •Diagnosis of type 2 diabetes mellitus ≥1 year
- •Stable medication ≥12 weeks
排除标准
- •Class 3 obesity
- •Hypertension not controled by medication
- •Diagnosis of cardiac, renal and/or pulmonary disease
- •Diagnosis of severe neuropathy and/or retinopathy
- •Insulin therapy
- •Fasting plasma triglycerides >5.0 mmol/L
- •Fasting total cholesterol >7 mmol/l
研究组 & 干预措施
Thermoneutral
Participants will immerse their feet in a foot bath with water maintained at 36°C
干预措施: Thermoneutral water (Other)
Heat
Participants will immerse their feet in a foot bath with water maintained at 42°C
干预措施: Hot water (Other)
结局指标
主要结局
Hemoglobin A1C (HbA1C)
时间窗: Change from baseline to 12 weeks
次要结局
- Postprandial metabolism following meal(Change from baseline to 12 weeks)
- Post-occlusion reactive hyperemia(Change from baseline to 12 weeks)
- Arterial stiffness(Change from baseline to 12 weeks)
- Insulin resistance (HOMA-IR)(Change from baseline to 12 weeks)
- Peripheral endothelial function(Change from baseline to 12 weeks)
- Ischemic handgrip exercise(Change from baseline to 12 weeks)
- Blood pressure(Change from baseline to 12 weeks)
研究者
Daniel Gagnon
Principal Investigator
Montreal Heart Institute