NCT02775253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

May 8, 2016

Last Update Submit

June 22, 2016

Conditions

Type 2 DiabetesCold Acclimation

Keywords

Brown adipose tissueSubcutaneous white adipose tissueWhite adipose tissue

Outcome Measures

Primary Outcomes (1)

  • 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.

    From baseline to 33 days

Study Arms (1)

Chronic cold acclimation group

EXPERIMENTAL

All patients will be conducted a chronic cold acclimation intervention for 33 days.

Other: Chronic cold acclimation

Interventions

Chronic cold acclimationOTHER
Chronic cold acclimation group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 diabetes
  • years old
  • Body mass index 18.5-28 kg/m2
  • HbA1c \< 6.5%
  • Well controlled diabetes

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Guangda Xiang, MD

CONTACT

+8602750772918Guangda64@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Endocrinol Dept.

Study Record Dates

First Submitted

May 8, 2016

First Posted

May 17, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

June 23, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)