Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight: Translational Controlled Trial Investigating Coldness and Training Effects on Endocrine Regulation on Energy Metabolism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
研究概览
简要总结
Therapeutic effectiveness of coldness in relieving pain and reducing inflammation has been known for many years now. Over that time, various coldness therapies have gained in popularity, including winter swimming, snow baths or whole body cryostimulation (WBC) . Recent researches have shown positive effects of WBC on metabolic profile, low-to-moderate chronic inflammation and related diseases (e.g., obesity). WBC could be, thus, intended as an adjuvant method in the treatment of dysmetabolic conditions, such as overweight or obesity. WBC is a cheap easily accessible practice, with a few well-defined contraindications and limited non severe possible adverse events, if performed in specialized centres. At the same time, in sport science appears data, which indicated on inhibition of adaptive changes induced by regular training.
The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 20 consecutive sessions of either WBC, high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight and obese subjects. The effects will be assessed, at different time-points, in terms of insulin sensitivity and modification in the profile of hormones regulating the energy metabolism (adipokines, myokines, bone-derived hormones) and the inter-organ cross-talk.
详细描述
Secondary aims are:
- To assess the influence of WBC and HIIT on insulin sensitivity and establish the role of myokines (irisin and IL-6) in this regulation. To find the answer for the question if the rise of mentioned myokines cause a decrease of authophagy protein HMGB1.
- To characterize potential effectiveness of these intervention protocols on bone and energy metabolisms by stimulating in vitro cultured normal human osteoblastic primary cells and β-pancreatic cells with sera obtained from patients at different time points during treatment.
- To establish, which procedure is most effective at improving insulin sensitivity: training or training supported with WBC treatment, which factors modify this response (body composition or physical capacity of subjects)
- To establish if training supported with WBC treatment impairs adaptive changes of trained subjects
- To determine the potential beneficial effects of the intervention protocols on the metabolic homeostasis, and assess how long these changes are maintained over a period of four weeks or three months.
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
- Single (Participant)
盲法说明
4 groups of obese patients will take part in the study. Qualification for the test is insulin resistance, abdominal obesity, lack of physical activity, lack of cold sensitivity.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obesity (BMI >30kg/m2),
- •age >18 years,
- •diagnosis of impaired glucose tolerance (IGT),
- •functional autonomy,
- •ability to discernment,
- •no WBC treatment within the previous year.
排除标准
- •using insulin or other chronic medications,
- •inflammatory/immune-mediated pathologies,
- •liver or kidney disease,
- •cardiovascular diseases,
- •neuropathy, retinopathy,
- •neoplasia, as well as fragility fractures of bones,
- •traumatic fractures in the previous 2 years,
- •contraindications for WBC and exercise
结局指标
主要结局
The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
时间窗: one month
Proinflammatory: HMGB1 ng/ml, CRP ng/ml TNFalpha pg/ml Anti-inflammaotry: Irisin ng/ml Adiponectin ng/ml Leptin ng/lm IL-10 pg/ml
次要结局
- Assessment of insulin sensitivity and insulin resistance(one month)
研究者
Robert Olek
Professor
Gdansk University of Physical Education and Sport