Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes, Cold Acclimation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Chronic cold acclimation
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Brown adipose tissue, Subcutaneous white adipose tissue, White adipose tissue
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- 18-60 years old
- Body mass index 18.5-28 kg/m2
- HbA1c < 6.5%
- Well controlled diabetes
Exclusion Criteria:
- Type 1 diabetes
- Body mass index < 18.5 kg/m2
- Body mass index > 28 kg/m2
- Female
- Taking any drugs other than metformin
- haemoglobinA1c >=6.50%
Sites / Locations
- Wuhan General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chronic cold acclimation group
Arm Description
All patients will be conducted a chronic cold acclimation intervention for 33 days.
Outcomes
Primary Outcome Measures
The changes of UCP-1 expression in subcutaneous white adipose before and after cold acclimation program
The expression differences (fold) will be compared before and after cold acclimation program in UCP-1.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02775253
Brief Title
Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus
Official Title
Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiang Guang-da
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 an antidiabetic benefits. More recently, one study showed that Short-term cold acclimation (10 days) improved insulin sensitivity, but did not activate the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus. Here, investigators hypothesize that a chronic cold acclimation can activate the the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus.
Detailed Description
All subjects must receive metformin therapy, Patients have chronic cold acclimation intervention for 33 days. During the subsequent cold acclimation period, subjects are exposed to an environmental temperature of 14-15 °C for 33 consecutive days, with cold exposure for 2 h on the first day, 4 h on the second day and 6 h on the third through the 33th day.Biopsy for subcutaneous white adipose and skeletal muscle was performed before and after the intervention program under local anesthesia. The brown fat characteristics and insulin signaling of biopsy samples will be measured. The expression levels of uncoupling protein-1 (UCP-1), 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 the intervention programme from the biopsy samples. In addition, a combination of positron emission tomography (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 the intervention programme.Insulin sensitivity will be checked before and after the intervention programme by insulin clamp assay, and endothelial function will be measured by ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Cold Acclimation
Keywords
Brown adipose tissue, Subcutaneous white adipose tissue, White adipose tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic cold acclimation group
Arm Type
Experimental
Arm Description
All patients will be conducted a chronic cold acclimation intervention for 33 days.
Intervention Type
Other
Intervention Name(s)
Chronic cold acclimation
Primary Outcome Measure Information:
Title
The changes of UCP-1 expression in subcutaneous white adipose before and after cold acclimation program
Description
The expression differences (fold) will be compared before and after cold acclimation program in UCP-1.
Time Frame
From baseline to 33 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
18-60 years old
Body mass index 18.5-28 kg/m2
HbA1c < 6.5%
Well controlled diabetes
Exclusion Criteria:
Type 1 diabetes
Body mass index < 18.5 kg/m2
Body mass index > 28 kg/m2
Female
Taking any drugs other than metformin
haemoglobinA1c >=6.50%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangda Xiang, MD
Phone
+8602750772918
Email
Guangda64@hotmail.com
Facility Information:
Facility Name
Wuhan General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangda Xiang, MD, PhD
Phone
+8602750772918
Email
Guangda64@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus
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