Trial Outcomes & Findings for Does Cold Provocation Increase Brown Adipose Tissue Volume? (NCT NCT01797328)

NCT ID: NCT01797328

Last Updated: 2017-04-25

Results Overview

Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: Baseline and 6 week
• Results posted on: 2017-04-25

Participant Flow

Participant milestones

Measure	Cold Provocation cold arm cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering	to Avoid Feeling Cold warm arm warm arm: To the best of ability avoid feeling cold during 6 weeks
Overall Study STARTED	16	12
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

because there were 14 who did the study

Baseline characteristics by cohort

Measure	Cold Provocation n=16 Participants cold arm cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering	to Avoid Feeling Cold n=12 Participants warm arm warm arm: To the best of ability avoid feeling cold during 6 weeks	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=12 Participants	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants	12 Participants n=12 Participants	28 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants	0 Participants n=12 Participants	0 Participants n=28 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 3.9 • n=14 Participants • because there were 14 who did the study	24.3 years STANDARD_DEVIATION 2.9 • n=12 Participants • because there were 14 who did the study	25.3 years STANDARD_DEVIATION 3.5 • n=26 Participants • because there were 14 who did the study
Sex: Female, Male Female	9 Participants n=14 Participants • because 2 did not do the study at all	7 Participants n=12 Participants • because 2 did not do the study at all	16 Participants n=26 Participants • because 2 did not do the study at all
Sex: Female, Male Male	5 Participants n=14 Participants • because 2 did not do the study at all	5 Participants n=12 Participants • because 2 did not do the study at all	10 Participants n=26 Participants • because 2 did not do the study at all
Region of Enrollment Sweden	16 participants n=16 Participants	12 participants n=12 Participants	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Baseline and 6 week

Population: Brown adipose tissue volume (liters)

Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)

Outcome measures

Measure	Cold Provocation n=13 Participants cold arm cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering	to Avoid Feeling Cold n=12 Participants warm arm warm arm: To the best of ability avoid feeling cold during 6 weeks
Brown Adipose Tissue, Absolute Volume	0.0066 liters Standard Deviation 0.012	0.0021 liters Standard Deviation 0.0086

Adverse Events

Cold Provocation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

to Avoid Feeling Cold

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fredrik H Nystrom

UHLinkopeing

Phone: +46101037749

Email: fredrik.h.nystrom@liu.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place