- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159144
Cold Stress Stimulate the Browing of Subcutaneous White Adipose in Healthy Adults
August 11, 2015 updated by: Xiang Guang-da
Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT), play an essential role in regulating whole-body energy homeostasis.
Recent studies also reveal the presence of a subset of cells in WAT that could be induced by environmental or hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong antiobesity and antidiabetic benefits.
More recently, same studies showed that cold stress stimulate the browning of subcutaneous white adipose.
However, to the investigators knowledge, there are no direct data that clearly show that cold stress can promote the browning of subcutaneous white adipose.
Study Overview
Detailed Description
Individuals have cold exposure at 15C for 2 hr everyday for one week.Biopsy for subcutaneous white adipose was performed before and after one week cold exposure programme under local anesthesia.
Measure the brown fat characteristics of biopsy samples.
The expression levels of uncoupling protein-1 (UCP-1), peroxisome proliferator-activated receptor (PPAR)-r, peroxisome proliferator-activated receptor r coactivator 1 a (PGC1a) , growth factor receptor binding protein-10 (Grb10), PR domain containing 16 (PRDM16) will be determined before and after cold stress programme from the biopsy samples.
In addition, a combination of PET and computed tomography (CT) - with the glucose analogue 18F-fluorodeoxyglucose (18F-FDG) as a tracer will be performed for brown adipose tissue before and after cold stress programme.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430070
- Wuhan General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy men
- 18-60 years old
- BMI 20-28 kg/m2
Exclusion Criteria:
- BMI < 20 kg/m2
- BMI > 28 KG/M2
- Female
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: healthy adults
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
browning of subcutaneous white adipose
Time Frame: 4 months
|
Brown fat characteristics of biopsy samples will be assessed by determining the expression levels of UCP1, PGC1a, PRDM16 and Grb10.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
May 31, 2014
First Submitted That Met QC Criteria
June 5, 2014
First Posted (ESTIMATE)
June 9, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 2014Wze088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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