Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 9:04 AM
Study NCT ID:
NCT04375969
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Expresion of proteins induced by serum collected from our subjects', 'timeFrame': '3 months', 'description': 'Human osteoblasts and β-pancreatic cell line will be treated by serum, which comes from our participants'}, {'measure': 'Body composition assessment', 'timeFrame': 'one month', 'description': 'assessment of weight \\[kg\\], skeletal muscle mass \\[kg\\], fat tissue \\[kg\\]'}], 'primaryOutcomes': [{'measure': 'The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.', 'timeFrame': 'one month', 'description': 'Proinflammatory:\n\nHMGB1 ng/ml, CRP ng/ml TNFalpha pg/ml\n\nAnti-inflammaotry:\n\nIrisin ng/ml Adiponectin ng/ml Leptin ng/lm IL-10 pg/ml'}], 'secondaryOutcomes': [{'measure': 'Assessment of insulin sensitivity and insulin resistance', 'timeFrame': 'one month', 'description': 'Measurement of fasting glucose and after oral glucose test concentration:\n\nglucose mg/ml insulin ng/ml, calculating Matsuda and HOMA indicators based on glucose and insulin concentrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cold treatment', 'insulin resistance', 'HIIT', 'cell cultures line'], 'conditions': ['Cryotherapy', 'Training', 'Overweight', 'Insulin']}, 'referencesModule': {'references': [{'pmid': '28512432', 'type': 'BACKGROUND', '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.'}, {'pmid': '26475491', 'type': 'BACKGROUND', '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.'}, {'pmid': '24998353', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': 'Secondary aims are:\n\n1. 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.\n2. 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.\n3. 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)\n4. To establish if training supported with WBC treatment impairs adaptive changes of trained subjects\n5. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity (BMI \\>30kg/m2),\n* age \\>18 years,\n* diagnosis of impaired glucose tolerance (IGT),\n* functional autonomy,\n* ability to discernment,\n* no WBC treatment within the previous year.\n\nExclusion Criteria:\n\n* using insulin or other chronic medications,\n* inflammatory/immune-mediated pathologies,\n* T2D,\n* liver or kidney disease,\n* cardiovascular diseases,\n* neuropathy, retinopathy,\n* neoplasia, as well as fragility fractures of bones,\n* traumatic fractures in the previous 2 years,\n* contraindications for WBC and exercise'}, 'identificationModule': {'nctId': 'NCT04375969', 'briefTitle': 'Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight', 'organization': {'class': 'OTHER', 'fullName': 'Gdansk University of Physical Education and Sport'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NCN 2017/25/B/NZ7/02309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'whole body cryostimulation treatment', '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.', 'interventionNames': ['Other: whole body cryostimulation treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Connection WBC treatment and HIIT training', 'description': 'This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC.', 'interventionNames': ['Other: Connection WBC treatment and HIIT training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Control group who will be investigated (meanwhile at baseline and after the interventions)', 'interventionNames': ['Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'HIIT training group', 'description': 'This group will perform only HIIT protocol without cryo-sessions', 'interventionNames': ['Other: HIIT training group']}], 'interventions': [{'name': 'whole body cryostimulation treatment', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['whole body cryostimulation treatment']}, {'name': 'Connection WBC treatment and HIIT training', 'type': 'OTHER', 'description': 'WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions', 'armGroupLabels': ['Connection WBC treatment and HIIT training']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study', 'armGroupLabels': ['Control Group']}, {'name': 'HIIT training group', 'type': 'OTHER', 'description': 'This group will do the training program without cold exposure', 'armGroupLabels': ['HIIT training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81-735', 'city': 'Sopot', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Ziemann Ewa', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}], 'overallOfficials': [{'name': 'Ewa Ziemann, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gdansk University of Physical Education and Sport', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Olek', 'investigatorAffiliation': 'Gdansk University of Physical Education and Sport'}}}}