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

NCT04375969 | Unknown

• 1 other identifier: NCN 2017/25/B/NZ7/02309
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy; Training; Overweight; Insulin

Keywords

cold treatment; insulin resistance; HIIT; cell cultures line

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of insulin sensitivity and insulin resistance

  one month

Other Outcomes (2)

• Expresion of proteins induced by serum collected from our subjects

  3 months

• Body composition assessment

  one month

Study Arms (4)

whole body cryostimulation treatment

EXPERIMENTAL

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.

Other: whole body cryostimulation treatment

Connection WBC treatment and HIIT training

EXPERIMENTAL

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

Other: Connection WBC treatment and HIIT training

Control Group

ACTIVE COMPARATOR

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

Other: Control Group

HIIT training group

EXPERIMENTAL

This group will perform only HIIT protocol without cryo-sessions

Other: HIIT training group

Interventions

whole body cryostimulation treatment OTHER

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.

whole body cryostimulation treatment

Connection WBC treatment and HIIT training OTHER

WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions

Connection WBC treatment and HIIT training

Control Group OTHER

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

Control Group

HIIT training group OTHER

This group will do the training program without cold exposure

HIIT training group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead

Study Sites (1)

Ziemann Ewa

Sopot, Pomeranian Voivodeship, 81-735, Poland

Location

Related Publications (3)

• 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.

  PMID: 28512432 BACKGROUND

• 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.

  PMID: 26475491 BACKGROUND

• 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.

  PMID: 24998353 BACKGROUND

MeSH Terms

Conditions

Overweight; Insulin Resistance

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ewa Ziemann, Professor

  Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: January 3, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

PL (1)