The Effect of HEAT Therapy on patiEnts With Type 2 Diabetes Mellitus (HEATED): Protocol of a Randomized, Two-arm Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in hemoglobin A1c level
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is a significant burden worldwide. In addition to lifestyle intervention, heat therapy has been shown to be effective in improving glycemic control. To date, there are no randomized, controlled trials investigating the efficacy of heat therapy in T2DM. Our aim is to investigate whether heat therapy with natural mineral water can improve blood glucose status in T2DM patients.
The HEATED study is a two-arm, randomized, controlled study. Patients with T2DM were randomly assigned to Group A (bath in 38 ° C natural thermal mineral water) or Group B (bath in thermoneutral water - 30-32 ° C). Both groups participate in up to five interventions per week, representing 50 to 60 heat therapies over the 12-week study. Each intervention lasts 30 minutes, preceded by a medical examination.
详细描述
Type 2 diabetes mellitus (T2DM) is a significant burden worldwide. In addition to lifestyle intervention, heat therapy has been shown to be effective in improving glycemic control. To date, there are no randomized, controlled trials investigating the efficacy of heat therapy in T2DM. The study aims to investigate whether heat therapy with natural mineral water can improve blood glucose status in T2DM patients.
The HEATED study is a two-arm, randomized, controlled study. Patients with T2DM will be randomly assigned to Group A (bath in 38 ° C natural thermal mineral water) or Group B (bath in thermoneutral water - 30-32 ° C). Both groups will participate in up to five interventions per week, representing 50 to 60 heat therapies over the 12-week study. Each intervention will last 30 minutes, preceded by a medical examination. At baseline, patients' T2DM status will be recorded and possible micro- and macrovascular complications of T2DM are assessed by physical and laboratory tests. In addition, sensory and autonomic neuropathy will be assessed using Neurometer, Neuropad, and 128 Hz tuning fork tests. Quality of life will be assessed using the SF-36 questionnaire. In addition to baseline, patient data will be recorded at 4, 8, and 12 weeks. During routine blood collection, biobank storage will be performed via plus blood samples collection.
The primary endpoint will be the change from baseline in glycated hemoglobin by week 12 in both groups. Based on a preliminary estimate of the number of items, 65 patients per group are planned to be included in the HEATED study.
The results of the study described above may provide information on the utility of heat therapy in type 2 diabetics. Using the samples stored in the biobank, further analyzes will be performed at the end of the study.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with type 2 diabetes diagnosed according to the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) guidelines
- •serum glycated hemoglobin (HbA1c) level between 7 and 10% (53-86 mmol/mol)
- •signed written informed consent form
排除标准
- •other types of diabetes mellitus
- •patients with poor glycaemic control or unstable diabetes
- •patients with known serious comorbidity and/ or with advanced macrovascular complications
- •active bacterial infection or treatment with antibiotics within 3 weeks
- •open wounds or skin lesions
- •history of skin-related conditions or sensitivity to prolonged water immersion or exposure to pool chemicals
- •severe psychiatric pathology or psychosis
- •pregnancy or breastfeeding
- •judgment by medical provider that heat therapy/ hydrotherapy poses an undue burden or risk
- •participating in other ongoing clinical trials
- •heat or balneotherapy in the past 3 months
- •morbid obesity (body mass index > 40 kg/m2)
- •steroid treatment
- •active autoimmune diseases
- •coronavirus disease 2019 (COVID-19) in the past 3 months
结局指标
主要结局
Change in hemoglobin A1c level
时间窗: 12 weeks
The absolut changes in the hemoglobin A1c from baseline to 12-weeks between the two groups will be compared.
次要结局
- Change in mean blood pressure(4,8, and 12-weeks)
- Change in the proportion of nephropathy(4,8, and 12-weeks)
- Change in total cholesterol level(4,8, and 12-weeks)
- Change in low-density lipoprotein cholesterol level(4,8, and 12-weeks)
- Change in hemoglobin A1c level(4 and 8 weeks)
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(4,8, and 12-weeks)
- Change in body mass index(4,8, and 12-weeks)
- Change in the proportion of retinopathy(4,8, and 12-weeks)
- Change in triglyceride level(4,8, and 12-weeks)
- Change in creatinine level(4,8, and 12-weeks)
- Insulin signaling in polymorphonuclear cells(4,8, and 12-weeks)
- Change in gamma-glutamyl transferase (GGT).(4,8, and 12-weeks)
- Change in fasting plasma glucose(4,8, and 12-weeks)
- Change in the proportion of hypertension(4,8, and 12-weeks)
- Change in alkaline phosphatase (ALP)(4,8, and 12-weeks)
- Decrease of daily insulin dose(4,8, and 12-weeks)
- Change in the prevalence of electrocardiogram events(4,8, and 12-weeks)
- Change in high-density lipoprotein cholesterol level(4,8, and 12-weeks)
- Change in glomerular filtration rate(4,8, and 12-weeks)
- Change in thrombocyte aggregation(4,8, and 12-weeks)
- Heat Shock Protein expression(4,8, and 12-weeks)
- Lipidom of plasma cells(4,8, and 12-weeks)
- Change in fasting insulin(4,8, and 12-weeks)
- Change in heart output(4,8, and 12-weeks)
- Change in the proportion of neuropathy(4,8, and 12-weeks)
- Change in aspartate transaminase (AST)(4,8, and 12-weeks)
- Change in alanine transaminase (ALT)(4,8, and 12-weeks)
- Lipidom of polymorphonuclear cells(4,8, and 12-weeks)
- Change in obstructive sleep apnea proportion(4,8, and 12-weeks)
- Change in the proportion of abnormal overnight pulse oximetry(4,8, and 12-weeks)
- Change in 24-hour blood pressure(4,8, and 12-weeks)
研究者
Dr Hegyi Péter
Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs
University of Pecs