NCT02170324

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. Excess expansion of WAT due to positive energy balance and defects in thermogenic gene expression in BAT are associated with obesity and various metabolic diseases. Until 2009 the question of whether adult humans had BAT and whether it could conceivably contribute to whole body energy usage in a meaningful way was a matter of vigorous debate. The publication of three apppers in the New England Journal of Medicine that demonstrated adult humans do have BAT, that it can be activated, and that this activation appears to be defective in obesity reframed the debate, and revived interest in BAT physiology. 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. The extrapancreatic actions of glucagon-like peptide-1 (GLP-1) on endothelial cells and the liver have been reported. Additionally, effects of GLP-1 on adipose tissue have been described. Studies performed in isolated adipocytes have demonstrated that GLP-1 has the ability to induce both lipogenic and lipolytic mechanisms in white adipose tissue (WAT) . More recent study showed that GLP-1 agonism stimulates brown adipose tissue thermogenesis and browning through hypothalamic AMP-activated protein kinase (AMPK) in animal. However, there is no data clearly show that GLP-1 agonism stimulates browning of subcutaneous white adipose tissue (SWAT) in human obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4 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

Study Start

First participant enrolled

June 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

June 17, 2014

Last Update Submit

January 14, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • The expression of brown adipose related genes in subcutaneous white adipose tissue

    Brown fat characteristics of biopsy samples will be assessed by determining 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); 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 GLP-1 agonism treatment programme.

    3 months

Study Arms (2)

GLP-1 agonism group

EXPERIMENTAL

Exenatide injection 10 ug twice daily for 10 days subcutaneously.

Drug: Exenatide

Placebo group

PLACEBO COMPARATOR

0.9 % sodium choride 0.1 ml twice daily for 10 days subcutaneously.

Drug: Placebo

Interventions

ExenatideDRUG
GLP-1 agonism group
PlaceboDRUG
Placebo group

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) \> 30 kg/m2
  • Men
  • Age 20 - 30 years old

You may not qualify if:

  • BMI \< 30 kg/m2
  • Diabetes
  • Hypertension
  • Use of medicines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Exenatide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Endocrinology Dept.

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 23, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

CN(1)