Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cryotherapy, Training, Overweight, Insulin

Intervention / Treatment
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* Other: whole body cryostimulation treatment
* Other: Connection WBC treatment and HIIT training
* Other: Control Group
* Other: HIIT training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: using insulin or other chronic medications, inflammatory/immune-mediated pathologies, T2D, 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 10-20 consecutive sessions of either whole body cryostimulation (WBC), high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole body cryostimulation treatment<br>WBC will be performed at the Pomeranian Rheumatologic Centre in Sopot. The centre is equipped with an electric cryochamber Zimmer Medicine System, Cryochamber ELECPOL, located in a temperature- and humidity-controlled room. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes. | Other: whole body cryostimulation treatment<br>* The WBC is apporved by National Ministry of Health. It uses cryochamber with low temperature -110 oC. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes.<br>|
| Experimental: Connection WBC treatment and HIIT training<br>This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC. | Other: Connection WBC treatment and HIIT training<br>* WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions<br>|
| Active Comparator: Control Group<br>Control group who will be investigated (meanwhile at baseline and after the interventions) | Other: Control Group<br>* This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study<br>|
| Experimental: HIIT training group<br>This group will perform only HIIT protocol without cryo-sessions | Other: HIIT training group<br>* This group will do the training program without cold exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures. | 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 | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of insulin sensitivity and insulin resistance | Measurement of fasting glucose and after oral glucose test concentration: glucose mg/ml insulin ng/ml, calculating Matsuda and HOMA indicators based on glucose and insulin concentrations | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold treatment, insulin resistance, HIIT, cell cultures line