Clinical trial

Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03541096

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionAdipose Tissue, Brown, Brown Adipose Tissue, Uncoupling Protein 1, Cold Exposure, Obesity, Type 2 Diabetes Mellitus, Winter Swimming

Full registry 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.

Treatments and study arms

Winter Swimming

Behavioral

Supervised Winter Swimming in Copenhagen

Control group

Behavioral

No winter swimming activities.

Primary outcomes

Difference between groups in change in brown adipose tissue (BAT) activity during coolingDay 0 (before intervention) and Day 120 (after intervention)

BAT activity is measured using positron emission tomography (PET)- Computer tomography (CT) scan. The PET-CT scan uses a glucose-radiotracer (fludeoxyglucose-18 (FDG)) to measure the glucose uptake in BAT, which is associated with BAT activity. FDG is injected following one hour of cooling and the subjects are scanned following one additional hour of cooling. The subjects are continuously cooled throughout the scanning procedure. Difference between groups in change in FDG tracer uptake (post minus pre intervention) during 1,5 hours of cooling is calculated.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Inflammation and Metabolism/ Center for Physical Activity Research🇩🇰 Copenhagen, Denmark