NCT02159144

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

May 31, 2014

Last Update Submit

August 11, 2015

Conditions

ObesityType 2 Diabetes

Keywords

Brown adipose tissueSubcutaneous white adipose tissueWhite adipose tissue

Outcome Measures

Primary Outcomes (1)

  • browning of subcutaneous white adipose

    Brown fat characteristics of biopsy samples will be assessed by determining the expression levels of UCP1, PGC1a, PRDM16 and Grb10.

    4 months

Study Arms (1)

healthy adults

EXPERIMENTAL
Other: cold stress

Interventions

cold stressOTHER
healthy adults

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men
  • years old
  • BMI 20-28 kg/m2

You may not qualify if:

  • BMI \< 20 kg/m2
  • BMI \> 28 KG/M2
  • Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

Cold-Shock Response

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Stress, PhysiologicalPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Endocrinology Department

Study Record Dates

First Submitted

May 31, 2014

First Posted

June 9, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

CN(1)