Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT). (WinterBAT)
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|ClinicalTrials.gov Identifier: NCT03541096|
Recruitment Status : Unknown
Verified November 2018 by Susanna Søberg, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : May 30, 2018
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adipose Tissue, Brown Brown Adipose Tissue Uncoupling Protein 1 Cold Exposure Obesity Type 2 Diabetes Mellitus Winter Swimming||Behavioral: Winter Swimming Behavioral: Control group||Not Applicable|
Brown fat (BAT) is an energy-consuming tissue. Long-term activation of BAT in adults increases clearance of blood glucose and non-esterified fatty acids (NEFA), insulin sensitivity and metabolic rate. Moreover, adipokines released from BAT, known as batokines, represent a promising but currently unexplored area in terms of metabolic regulation. Cooling activates BAT; however, current cooling protocols fail to activate BAT in a large part of the population. Whether this failure in activation is related to biology, inefficient detection or cooling protocols is unknown. With our initial acute cooling study (protocol number: H-16038581), these protocols have successfully been optimized whereupon novel batokines will be identified. Having established a methodology for assessing BAT activity and batokine profiles, a longer-term cooling intervention (winter swimming) will be performed to examine the effect of repetitive cold-water exposure on BAT activity. Obese pre-diabetic subjects will be included in a 4-month supervised winter swimming (WS) intervention.
It is hypothesized, that repetitive cold-water exposure constituted by WS, alters increase BAT activation and volume, followed by improved glycemic control in obese pre-diabetic subjects.
Method The study is a randomized controlled, parallel-group intervention study. The investigator will recruit 30 obese pre-diabetic non-winter-swimmers to participate in a WS intervention group (n=15) or control group (n=15) with no WS activities. Subjects will either be randomized to the WS group, who will winter-swim 4 months, 2-3 times/week including sauna-visits if desired, or control conditions with no WS during the 4 months (October to May).
- To assess whether WS will have an immediate effect on BAT recruitment or function.
- To assess whether WS will have an effect on glycemic control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Impact of Winter Swimming on Brown Adipose Tissue Recruitment and Metabolic Health in Middel-aged Obese Pre-diabetic Subjects.|
|Estimated Study Start Date :||November 7, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Experimental: Winter Swimmers
4 Months of supervised winter swimming.
Behavioral: Winter Swimming
Supervised Winter Swimming in Copenhagen
Placebo Comparator: Control group
No winter swimming activities.
Behavioral: Control group
No winter swimming activities.
- Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS). [ Time Frame: Difference in peak temperature after 2 hours of cooling. ]BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 3 hours of cooling is calculated.
- Difference in glycemic control after winter swimming [ Time Frame: Difference in glucose control after a 2 hour oral glucose tolerance test before versus after 4 months of winter swimming. ]Glycemic control is measured by a 2 hour oral glucose tolerance test. Difference in the 2 hour sample will be calculated before and after the 4 months winter swimming intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541096
|Contact: Susanna Søberg, PhDemail@example.com|
|Contact: Camilla Scheele, Assoc.Proffirstname.lastname@example.org|
|Center for Inflammation and Metabolism/ Center for Physical Activity Research||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Susanna Søberg, MSc. 0045 93565234 email@example.com|
|Principal Investigator:||Susanna Søberg, PhD-student||Center for Inflammation and Metabolism/Center for Physical Activity Research|