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

Not Applicable

• Conditions: Cryotherapy; Training; Overweight; Insulin
• Interventions: Other: Control Group; Other: Connection WBC treatment and HIIT training; Other: whole body cryostimulation treatment; Other: HIIT training group

• Registration Number: NCT04375969
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief Summary

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

Secondary aims are:

1. 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.

2. 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.

3. 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)

4. To establish if training supported with WBC treatment impairs adaptive changes of trained subjects

5. 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.

Study Timeline

• Study Start: 2018-01-03
• Primary Completion: 2019-12-30
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	Control group who will be investigated (meanwhile at baseline and after the interventions)
Connection WBC treatment and HIIT training	Connection WBC treatment and HIIT training	This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC.
whole body cryostimulation treatment	whole body cryostimulation treatment	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.
HIIT training group	HIIT training group	This group will perform only HIIT protocol without cryo-sessions

Primary Outcome Measures

Name	Time	Method
The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.	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

Secondary Outcome Measures

Name	Time	Method
Assessment of insulin sensitivity and insulin resistance	one month	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

Trial Locations

Locations (1)

Ziemann Ewa; 🇵🇱 Sopot, Pomorskie, Poland