Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT). (NCT03541096) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).
Denmark30 participantsStarted 2018-11-07
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, i…
What they're measuring
1
Difference between groups in change in brown adipose tissue (BAT) activity during cooling
Timeframe: Day 0 (before intervention) and Day 120 (after intervention)