Trials / Active Not Recruiting
Active Not RecruitingNCT03541096
Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).
The Impact of Winter Swimming on Brown Adipose Tissue Recruitment and Metabolic Health in Middel-aged Obese Pre-diabetic Subjects.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Kristian Karstoft · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates repetitive cold-water exposure on brown fat activity assessed by PET/CT scanning. Furthermore we will assess glucose control upon winter-swimming. Obese prediabetic men and women will be randomized to winter-swimming or control conditions for 4 months.
Detailed description
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, 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). Main aims * 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.
Conditions
- Adipose Tissue, Brown
- Brown Adipose Tissue
- Uncoupling Protein 1
- Cold Exposure
- Obesity
- Type 2 Diabetes Mellitus
- Winter Swimming
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Winter Swimming | Supervised Winter Swimming in Copenhagen |
| BEHAVIORAL | Control group | No winter swimming activities. |
Timeline
- Start date
- 2018-11-07
- Primary completion
- 2021-06-01
- Completion
- 2025-12-31
- First posted
- 2018-05-30
- Last updated
- 2025-08-17
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03541096. Inclusion in this directory is not an endorsement.