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Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02775253
Recruitment Status : Unknown
Verified June 2016 by Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : May 17, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Cold Acclimation Other: Chronic cold acclimation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus
Study Start Date : May 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chronic cold acclimation group
All patients will be conducted a chronic cold acclimation intervention for 33 days.
Other: Chronic cold acclimation



Primary Outcome Measures :
  1. The changes of UCP-1 expression in subcutaneous white adipose before and after cold acclimation program [ Time Frame: From baseline to 33 days ]
    The expression differences (fold) will be compared before and after cold acclimation program in UCP-1.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775253


Contacts
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Contact: Guangda Xiang, MD +8602750772918 Guangda64@hotmail.com

Locations
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China, Hubei
Wuhan General Hospital Recruiting
Wuhan, Hubei, China, 430070
Contact: Guangda Xiang, MD, PhD    +8602750772918    Guangda64@hotmail.com   
Sponsors and Collaborators
Xiang Guang-da

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Responsible Party: Xiang Guang-da, Director of Endocrinol Dept., Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02775253    
Other Study ID Numbers: 2016Wze005
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command:
Brown adipose tissue
Subcutaneous white adipose tissue
White adipose tissue
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases