Obesity Clinical Trial - Winter-Swimming & Brown Adipose Tissue Activity

Status Recruiting

Clinical Trial Summary

This study investigates repetitive cold-water exposure on brown fat activity assessed by infrared thermography imagine. 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.

Clinical Trial Description

Brown fat (BAT) is an energy-consuming tissue. Long-term activation of BAT in adults increases clearance of blood glucose and non-esterified fatty acids (NEFA), insulin sensitivity and metabolic rate. Moreover, adipokines released from BAT, known as batokines, represent a promising but currently unexplored area in terms of metabolic regulation. Cooling activates BAT; however, current cooling protocols fail to activate BAT in a large part of the population. Whether this failure in activation is related to biology, inefficient detection or cooling protocols is unknown. With our initial acute cooling study (protocol number: H-16038581), these protocols have successfully been optimized whereupon novel batokines will be identified. Having established a methodology for assessing BAT activity and batokine profiles, a longer-term cooling intervention (winter swimming) will be performed to examine the effect of repetitive cold-water exposure on BAT activity. Obese pre-diabetic subjects will be included in a 4-month supervised winter swimming (WS) intervention.

It is hypothesized, that repetitive cold-water exposure constituted by WS, alters increase BAT activation and volume, followed by improved glycemic control in obese pre-diabetic subjects.

Method The study is a randomized controlled, parallel-group intervention study. The investigator will recruit 30 obese pre-diabetic non-winter-swimmers to participate in a WS intervention group (n=15) or control group (n=15) with no WS activities. Subjects will either be randomized to the WS group, who will winter-swim 4 months, 2-3 times/week including sauna-visits if desired, or control conditions with no WS during the 4 months (October to May).

Main aims

- To assess whether WS will have an immediate effect on BAT recruitment or function.

- To assess whether WS will have an effect on glycemic control. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03541096
Study type	Interventional
Source	Rigshospitalet, Denmark
Contact	Susanna Søberg, PhD-st
Phone	22992757
Email	susannasoeberg@sund.ku.dk
Status	Recruiting
Phase	N/A
Start date	November 7, 2018
Completion date	June 1, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms