Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).
NCT ID: NCT03541096
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2018-11-07
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Winter Swimmers
4 Months of supervised winter swimming.
Winter Swimming
Supervised Winter Swimming in Copenhagen
Control group
No winter swimming activities.
Control group
No winter swimming activities.
Interventions
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Winter Swimming
Supervised Winter Swimming in Copenhagen
Control group
No winter swimming activities.
Eligibility Criteria
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Inclusion Criteria
* BMI \> 25 but \<40 kg/m2
* Age \> 40 years.
* Low to moderate physical activity level (no physical activity or on average 30 minutes of moderate physical activity per day and not more than 3 hours of training pr. Week)
Subjects will be included in either one of these cases after the screening:
* Fasting plasma glucose above 5.6 millimol per liter (mmoL/L).
* HbA1C \>39 millimol per mol (mmol/mol).
* 2 hour plasma glucose after a 75 g. oral glucose tolerance test (OGTT) above 7.8 mmol/L.
Exclusion Criteria
* Any history of Cancer,
* Clinically significant liver, kidney, heart, inflammatory or lung-disease.
* Pregnancy
* Taking medication (not for hay fever), including glucose-lowering treatment.
* HbA1c \>55 mmol/mol and/or 2-h plasma glucose in the 75-g OGTT \> 15 mmol/L, fasting plasma glucose above 6.9.
* Iron deficiency
* Increased International Normalised Ratio for coagulation (INR).
* Femoral hernia, vene prostheses (pants prosthesis), thrombs in v. Femoralis.
* Abnormal ultrasound echocardiography of the heart found at the health-examination day.
* Contraindications to cold exposure including severe Raynauds disease.
* History of alcohol abuse or use of more than 14 units pr. Week.
* History of drug abuse, including marihuana.
* Smoking including occasional smoking.
* Pacemaker or other electronics implanted in the body.
* Claustrophobia, communication problems, including understanding the experimental protocol.
* History of contrast allergy.
40 Years
ALL
No
Sponsors
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Kristian Karstoft
OTHER
Responsible Party
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Kristian Karstoft
MD, PhD, Chief Physician
Principal Investigators
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Camilla Schéele, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Center for Inflammation and Metabolism/ Center for Physical Activity Research
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-18015882 WinterBAT-Study
Identifier Type: -
Identifier Source: org_study_id
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