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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight; Training; Insulin; Cryotherapy
• Intervention / Treatment: Other: whole body cryostimulation treatment; Other: Connection WBC treatment and HIIT training; Other: Control Group; Other: HIIT training group

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Pomorskie
    • Sopot, Pomorskie, Poland, 81-735
      • Ziemann Ewa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: whole body cryostimulation treatment; 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.
Experimental: Connection WBC treatment and HIIT training; This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC.	Other: Connection WBC treatment and HIIT training; WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions
Active Comparator: Control Group; Control group who will be investigated (meanwhile at baseline and after the interventions)	Other: Control Group; This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study
Experimental: HIIT training group; This group will perform only HIIT protocol without cryo-sessions	Other: HIIT training group; This group will do the training program without cold exposure

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expresion of proteins induced by serum collected from our subjects	Human osteoblasts and β-pancreatic cell line will be treated by serum, which comes from our participants	3 months
Body composition assessment	assessment of weight [kg], skeletal muscle mass [kg], fat tissue [kg]	one month

Collaborators and Investigators

• Sponsor: Gdansk University of Physical Education and Sport
• Investigators: Principal Investigator: Ewa Ziemann, Professor, Poznań University of Physical Education

Publications and helpful links

General Publications

• Lombardi G, Ziemann E, Banfi G. Whole-Body Cryotherapy in Athletes: From Therapy to Stimulation. An Updated Review of the Literature. Front Physiol. 2017 May 2;8:258. doi: 10.3389/fphys.2017.00258. eCollection 2017.
• Dulian K, Laskowski R, Grzywacz T, Kujach S, Flis DJ, Smaruj M, Ziemann E. The whole body cryostimulation modifies irisin concentration and reduces inflammation in middle aged, obese men. Cryobiology. 2015 Dec;71(3):398-404. doi: 10.1016/j.cryobiol.2015.10.143. Epub 2015 Oct 22.
• Ziemann E, Olek RA, Grzywacz T, Kaczor JJ, Antosiewicz J, Skrobot W, Kujach S, Laskowski R. Whole-body cryostimulation as an effective way of reducing exercise-induced inflammation and blood cholesterol in young men. Eur Cytokine Netw. 2014 Mar 1;25(1):14-23. doi: 10.1684/ecn.2014.0349.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: insulin resistance; HIIT; cold treatment; cell cultures line
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperinsulinism; Insulin Resistance; Overweight
• Other Study ID Numbers: NCN 2017/25/B/NZ7/02309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No