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

Gdansk University of Physical Education and Sport

Status

Unknown

Conditions

Overweight

Training

Insulin

Cryotherapy

Treatments

Other: Connection WBC treatment and HIIT training

Other: HIIT training group

Other: Control Group

Other: whole body cryostimulation treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04375969

NCN 2017/25/B/NZ7/02309

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 4 patient groups

whole body cryostimulation treatment

Experimental group

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.

Treatment:

Other: whole body cryostimulation treatment

Connection WBC treatment and HIIT training

Experimental group

Description:

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

Treatment:

Other: Connection WBC treatment and HIIT training

Control Group

Active Comparator group

Description:

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