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

Sponsor
Gdansk University of Physical Education and Sport (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04375969
Collaborator
(none)
80
1
4
47.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: whole body cryostimulation treatment
  • Other: Connection WBC treatment and HIIT training
  • Other: Control Group
  • Other: HIIT training group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Jan 3, 2018
Actual Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Other Outcome Measures

  1. Expresion of proteins induced by serum collected from our subjects [3 months]

    Human osteoblasts and β-pancreatic cell line will be treated by serum, which comes from our participants

  2. Body composition assessment [one month]

    assessment of weight [kg], skeletal muscle mass [kg], fat tissue [kg]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ziemann Ewa Sopot Pomorskie Poland 81-735

Sponsors and Collaborators

  • Gdansk University of Physical Education and Sport

Investigators

  • Principal Investigator: Ewa Ziemann, Professor, Poznan University of Physical Education

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Robert Olek, Professor, Gdansk University of Physical Education and Sport
ClinicalTrials.gov Identifier:
NCT04375969
Other Study ID Numbers:
  • NCN 2017/25/B/NZ7/02309
First Posted:
May 6, 2020
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Robert Olek, Professor, Gdansk University of Physical Education and Sport
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2021