Overweight Clinical Trial
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
Verified date | May 2021 |
Source | Gdansk University of Physical Education and Sport |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Ziemann Ewa | Sopot | Pomorskie |
Lead Sponsor | Collaborator |
---|---|
Gdansk University of Physical Education and Sport |
Poland,
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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Expresion of proteins induced by serum collected from our subjects | Human osteoblasts and ß-pancreatic cell line will be treated by serum, which comes from our participants | 3 months | |
Other | Body composition assessment | assessment of weight [kg], skeletal muscle mass [kg], fat tissue [kg] | one month | |
Primary | 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 | Assessment of insulin sensitivity and insulin resistance | Measurement 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 |
one month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Terminated |
NCT03299881 -
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
|
N/A | |
Completed |
NCT02805478 -
Fat-Associated Cardiovascular Organ Dysfunction
|
||
Active, not recruiting |
NCT02558920 -
Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
|
||
Completed |
NCT03759743 -
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
|
N/A | |
Completed |
NCT03610958 -
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
|
N/A | |
Completed |
NCT03678766 -
CHARGE: Controlling Hunger and ReGulating Eating
|
N/A | |
Completed |
NCT04430465 -
Effects of Wholegrains on Children's Health (KORN)
|
N/A | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT05376865 -
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
|
N/A | |
Completed |
NCT03625427 -
Effect of Palmitoleic Acid on C-reactive Protein
|
N/A | |
Active, not recruiting |
NCT03435445 -
Online Platform for Healthy Weight Loss (POEmaS)
|
N/A | |
Enrolling by invitation |
NCT05576116 -
Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
|
N/A | |
Recruiting |
NCT05249465 -
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
|
N/A | |
Active, not recruiting |
NCT06023095 -
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
|
Phase 1 | |
Completed |
NCT03648892 -
Brain Dopamine Function in Human Obesity
|
Early Phase 1 | |
Not yet recruiting |
NCT05751993 -
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
|
N/A | |
Recruiting |
NCT02887950 -
Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause
|
N/A | |
Completed |
NCT03097237 -
High Fiber Rye Foods for Weight and Body Fat Reduction
|
N/A | |
Completed |
NCT02899390 -
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
|
N/A |