Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers

Type2 Diabetes Clinical Trial

— COLDBAT_WS  

Official title:

Cold Induced Activation of Brown Fat in Winter Swimmers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095846
• Other study ID #: H-16038581-COLDBAT_WS
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: March 23, 2018
• Start date: April 2, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.

Description:

The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood.

Cold induced brown fat activity will be measured by skin temperature measures by means of infra-red thermography imaging and skin temperature.

15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

Age 18-35 years. Men Caucasian white Body Mass Index 19-25 kg/m2. Moderate physical activity level (not more than 8-10 hours of training pr. Week) Ability to give informed consent. Ability to follow verbal and written instructions in Danish. Body fat percent under 21% measured at the pre-examination day. Winter swimmers: Min. 2 swim/ week. Swimming in winter-season in open water outdoor in Denmark from September/October until study start in March.

Not-winter swimmers: Not winter-swimmers or taken cold showers on a regular basis.

Exclusion Criteria:

• Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.

Tobacco, marijuana or intravenous drug use within 1 year of screening. Dieting, recent weight loss (>3 kg within 3 month) or a history of an eating disorder.

Dietary supplements. History of depression, psychosis, or other psychiatric illness requiring hospitalization.

Alcohol consumption >14 units/week. History of alcohol abuse within the past 3 years. Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.

Known kidney disease or elevated kidney biomarkers, in the preliminary investigation.

Use of daily medications, except for seasonal use of antihistamines. Diagnosed sleep disturbances.

Related Conditions & MeSH terms

• Adipokines
• Adipose Tissue
• BAT
• Brown Adipose Tissue
• Brown Fat
• Infra-red Thermography
• Proteins
• Proteomics
• Type2 Diabetes
• Uncoupling Protein 1
• Winter Swimmers

Intervention

Procedure:
• Cooling
Individualized cooling protocol

Locations

Country	Name	City	State
Denmark	Center for Inflammation and Metabolism/ Center for Physical Activity Research	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5. Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS).	BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 2 hours of cooling is calculated.	Difference in peak temperature after 2 hours of cooling.
Secondary	Difference in glucose control between WS and NWS.	Difference in glucose control between WS and NWS in an oral glucose tolerance test measured as incremental area under the curve (iAUC).	Difference in glucose control between WS and NWS after a 2 hours glucose tolerance test under thermoneutral conditions.
Secondary	Difference in resting energy expenditure after cooling versus no cooling	Difference in resting energy expenditure after cooling versus no cooling between WS and NWS measured as mean difference in kilojoule per minute.	Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.