The Impact of Passive Heat Treatment on Glycaemic Response During an Oral Glucose Tolerance Test in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Glycaemic response (Matsuda index)
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is a metabolic disease with a rapidly increasing incidence world-wide. The disease is characterizedby a decreased glucose tolerance as a result of insulin resistance, resulting in poor blood glycaemic control. Blood glucose loweringmedications are widely available, but their effect stagnates as T2DM progresses. New treatment regimens are required to combatthe disease. Although therapies such as physical exercise have been shown to induce beneficial effects on glycaemic control inT2DM patients, not all patients are able to perform exercise. Passive heating treatment (PHT) might be an alternative strategy toreduce insulin resistance, as it has been postulated to have comparable effects on the cardiovascular system as exercise. PHT hasbeen linked to numerous health benefits, including improved cardiovascular- and pulmonary function, pain alleviation and metabolichealth. In addition, long term use of PHT shows promising effects on glycaemic control in T2DM patients. However, the acute effectsof PHT on glucoregulation are yet to be determined. Therefore, in this study we will assess the acute impact of passive heat treatment on the post-prandial glycaemic response during an OGTT in T2DM patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
In this trial, neither the participants, nor the researchers who perform the trial days will be blinded to the intervention allocation. However, the researchers performing the blood analysis are blinded to the treatment allocation and are not involved in the research study during the trial days.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥50 years old
- •Body mass index 18.5 - 35 kg/m2
- •DM type 2
- •Using oral blood glucose lowering medication
- •Able to give informed consent
排除标准
- •Insulin dependence
- •Changes in diabetes medication in the past 3 months
- •Allergy for one of the food items used
- •>5% weight change in the previous 6 months
- •Participating in a structured (progressive) exercise program, or in the past 3 months.
- •Frequent (once per week or more) user of infrared (or traditional) sauna in the past 3 months
- •Inability to tolerate sauna/high temperatures
- •Diagnosed with cardiovascular disease (e.g. unstable angina pectoris or recent myocardial infarction), kidney failure (eGFR < 60 ml/min/1.73m2), rheumatoid arthritis
- •Diagnosed musculoskeletal, GI tract, metabolic (except diabetes) or pulmonary (e.g. COPD) disorders that are expected to influence study outcomes
- •Having a pacemaker, defibrillator, or any other type of metal implant
研究组 & 干预措施
Non-heated sauna session
The test days will consist of sitting in an infrared sauna cabin (HM-LSE-3 Professional edition, Health Mate, Belgium). Participants will sit in an infrared sauna at 21° Celsius for a total of 40 minutes.
干预措施: Sham sauna (Device)
Heated sauna session
The test days will consist of sitting in an infrared sauna cabin (HM-LSE-3 Professional edition, Health Mate, Belgium). Participants will sit in an infrared sauna at 60° Celsius (humidity not controlled in an infrared sauna) for a total of 40 minutes.
干预措施: Infrared sauna heating (Device)
结局指标
主要结局
Glycaemic response (Matsuda index)
时间窗: 120 minutes
OGTT
次要结局
- Gutt insulin sensitivity index(120 minutes)
- HOMA-IR(Baseline)
- Plasma volume/hematocrit(Throughout test day (3h))