Clinical trial NCT04375969: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cryotherapy
Training
Overweight
Insulin
Keywords: cold treatment
insulin resistance
HIIT
cell cultures line
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
timeFrame: one month
Secondary outcomes:
measure: Assessment of insulin sensitivity and insulin resistance
timeFrame: one month
Other outcomes:
measure: Expresion of proteins induced by serum collected from our subjects
timeFrame: 3 months
measure: Body composition assessment
timeFrame: one month
Locations:
city: Sopot
country: Poland
facility: Ziemann Ewa
state: Pomorskie
Study officials:
affiliation: Poznan University of Physical Education
name: Ewa Ziemann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.