Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).
Launched by KRISTIAN KARSTOFT · May 17, 2018
Trial Information
Current as of August 02, 2025
Active, not recruiting
Keywords
ClinConnect Summary
The WinterBAT trial is studying how regular exposure to cold water, like winter swimming, affects the activity of a specific type of fat in the body called brown fat. Brown fat helps burn calories and regulate blood sugar, which is important for people who are overweight or at risk of developing type 2 diabetes. The study will involve both men and women who are obese and have a waist size above certain measurements—80 cm for women and 94 cm for men. They should also have a body mass index (BMI) between 25 and 40 and be over 40 years old. Participants will be randomly assigned to either a winter swimming group or a control group for four months to see how this cold exposure impacts their blood sugar control.
If you join the trial, you can expect to either swim in cold water regularly or continue your usual routine without swimming for four months. It's important to note that certain health conditions and factors, like a history of cancer or specific heart and lung diseases, may prevent some people from participating. Additionally, if you are already a winter swimmer or taking certain medications, you may not be eligible. This study is currently active but not recruiting new participants, so it's a good opportunity to learn more about how cold exposure might help with weight and blood sugar management.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Waist circumference above 80 cm for women and 94 cm for men.
- • 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:
- • Winter swimmer
- • 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.
About Kristian Karstoft
Kristian Karstoft is a dedicated clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a strong background in clinical methodologies and a focus on innovative therapeutic approaches, he leads initiatives that explore cutting-edge treatments across various medical conditions. His collaborative approach fosters partnerships with academic institutions and healthcare professionals, ensuring rigorous study design and adherence to regulatory standards. Through his efforts, Kristian Karstoft aims to contribute significantly to the body of clinical knowledge and enhance the quality of care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Patients applied
Trial Officials
Camilla Schéele, PhD
Principal Investigator
Rigshospitalet, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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