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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04375969
Enrollment
80
Registered
2020-05-06
Start date
2018-01-03
Completion date
2021-12-30
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy, Insulin, Overweight, Training

Keywords

cold treatment, insulin resistance, HIIT, cell cultures line

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.

Interventions

OTHERwhole 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.

OTHERConnection 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

OTHERControl Group

This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study

OTHERHIIT training group

This group will do the training program without cold exposure

Sponsors

Gdansk University of Physical Education and Sport
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.one monthProinflammatory: 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

MeasureTime frameDescription
Assessment of insulin sensitivity and insulin resistanceone monthMeasurement 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

Other

MeasureTime frameDescription
Expresion of proteins induced by serum collected from our subjects3 monthsHuman osteoblasts and β-pancreatic cell line will be treated by serum, which comes from our participants
Body composition assessmentone monthassessment of weight \[kg\], skeletal muscle mass \[kg\], fat tissue \[kg\]

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026