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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04375969
Other study ID # NCN 2017/25/B/NZ7/02309
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 3, 2018
Est. completion date December 30, 2021

Study information

Verified date May 2021
Source Gdansk University of Physical Education and Sport
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 30, 2021
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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
Control Group
This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study
HIIT training group
This group will do the training program without cold exposure

Locations

Country Name City State
Poland Ziemann Ewa Sopot Pomorskie

Sponsors (1)

Lead Sponsor Collaborator
Gdansk University of Physical Education and Sport

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

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