Obesity Clinical Trial
— WinterBATOfficial title:
The Impact of Winter Swimming on Brown Adipose Tissue Recruitment and Metabolic Health in Middel-aged Obese Pre-diabetic Subjects.
Verified date | April 2024 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Inflammation and Metabolism/ Center for Physical Activity Research | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Kristian Karstoft |
Denmark,
Gibas-Dorna M, Checinska Z, Korek E, Kupsz J, Sowinska A, Krauss H. Cold Water Swimming Beneficially Modulates Insulin Sensitivity in Middle-Aged Individuals. J Aging Phys Act. 2016 Oct;24(4):547-554. doi: 10.1123/japa.2015-0222. Epub 2016 Aug 24. — View Citation
Hanssen MJ, Hoeks J, Brans B, van der Lans AA, Schaart G, van den Driessche JJ, Jorgensen JA, Boekschoten MV, Hesselink MK, Havekes B, Kersten S, Mottaghy FM, van Marken Lichtenbelt WD, Schrauwen P. Short-term cold acclimation improves insulin sensitivity in patients with type 2 diabetes mellitus. Nat Med. 2015 Aug;21(8):863-5. doi: 10.1038/nm.3891. Epub 2015 Jul 6. — View Citation
Hanssen MJ, van der Lans AA, Brans B, Hoeks J, Jardon KM, Schaart G, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Short-term Cold Acclimation Recruits Brown Adipose Tissue in Obese Humans. Diabetes. 2016 May;65(5):1179-89. doi: 10.2337/db15-1372. Epub 2015 Dec 30. — View Citation
Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22. — View Citation
van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718. Erratum In: N Engl J Med. 2009 Apr 30;360(18):1917. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between groups in change in brown adipose tissue (BAT) activity during cooling | 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. | Day 0 (before intervention) and Day 120 (after intervention) | |
Secondary | Difference between groups in change in glycemic control | Glycemic control is measured using a 4 hour mixed meal tolerance test. Difference between groups in change in the mean MMTT glucose levels during the MMTT (post minus pre intervention) will be calculated. | Day 0 (before intervention) and Day 120 (after intervention) |
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