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

Primary Purpose

Cryotherapy, Training, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
whole body cryostimulation treatment
Connection WBC treatment and HIIT training
Control Group
HIIT training group
Sponsored by
Gdansk University of Physical Education and Sport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cryotherapy focused on measuring cold treatment, insulin resistance, HIIT, cell cultures line

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ziemann Ewa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

whole body cryostimulation treatment

Connection WBC treatment and HIIT training

Control Group

HIIT training group

Arm Description

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.

This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC.

Control group who will be investigated (meanwhile at baseline and after the interventions)

This group will perform only HIIT protocol without cryo-sessions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2020
Last Updated
May 7, 2021
Sponsor
Gdansk University of Physical Education and Sport
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1. Study Identification

Unique Protocol Identification Number
NCT04375969
Brief Title
Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gdansk University of Physical Education and Sport

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy, Training, Overweight, Insulin
Keywords
cold treatment, insulin resistance, HIIT, cell cultures line

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
whole body cryostimulation treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Connection WBC treatment and HIIT training
Arm Type
Experimental
Arm Description
This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group who will be investigated (meanwhile at baseline and after the interventions)
Arm Title
HIIT training group
Arm Type
Experimental
Arm Description
This group will perform only HIIT protocol without cryo-sessions
Intervention Type
Other
Intervention Name(s)
whole body cryostimulation treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Connection WBC treatment and HIIT training
Intervention Description
WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study
Intervention Type
Other
Intervention Name(s)
HIIT training group
Intervention Description
This group will do the training program without cold exposure
Primary Outcome Measure Information:
Title
The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
Description
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
Time Frame
one month
Secondary Outcome Measure Information:
Title
Assessment of insulin sensitivity and insulin resistance
Description
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
Time Frame
one month
Other Pre-specified Outcome Measures:
Title
Expresion of proteins induced by serum collected from our subjects
Description
Human osteoblasts and β-pancreatic cell line will be treated by serum, which comes from our participants
Time Frame
3 months
Title
Body composition assessment
Description
assessment of weight [kg], skeletal muscle mass [kg], fat tissue [kg]
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Ziemann, Professor
Organizational Affiliation
Poznan University of Physical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziemann Ewa
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-735
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28512432
Citation
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.
Results Reference
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PubMed Identifier
26475491
Citation
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.
Results Reference
background
PubMed Identifier
24998353
Citation
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.
Results Reference
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Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight

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