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Clinical Trials/NCT04375969
NCT04375969
Unknown
Not Applicable

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

Gdansk University of Physical Education and Sport1 site in 1 country80 target enrollmentJanuary 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cryotherapy
Sponsor
Gdansk University of Physical Education and Sport
Enrollment
80
Locations
1
Primary Endpoint
The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2018
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gdansk University of Physical Education and Sport
Responsible Party
Principal Investigator
Principal Investigator

Robert Olek

Professor

Gdansk University of Physical Education and Sport

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,
  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Assessment of insulin sensitivity and insulin resistance(one month)

Study Sites (1)

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