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Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exenatide
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity; fat distribution; inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of overweight and type 2 diabetes mellitus

Exclusion Criteria:

  • Poor body condition (severe liver and kidney dysfunction)
  • Unknown causes of pancreatitis, chronic pancreatitis, pancreatic resection, stomach operation, malignant tumor, previous use of systemic corticosteroids (local or inhalation of exceptions) heart function or niacin, incomplete
  • serious endocrine disease
  • genetic disease

Sites / Locations

  • Shanghai Tenth People' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exenatide

Arm Description

exenatide, 5ug, bid, 3months

Outcomes

Primary Outcome Measures

Dual energy X-ray absorptiometry
fat distribution

Secondary Outcome Measures

lab testing
inflammation

Full Information

First Posted
December 20, 2013
Last Updated
April 16, 2014
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02118376
Brief Title
Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status
Official Title
Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status in Female Patients With Type 2 Diabetes and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state
Detailed Description
As a treatment for type 2 diabetesGlucagon like peptide -1 (Glucan-like peptide-1, GLP-1) receptor agonists plays the role of promoting insulin secretion, inhibiting glucagon secretion，and also has the central and peripheral effects,it can inhibit appetite,reduce weight.GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity; fat distribution; inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exenatide
Arm Type
Experimental
Arm Description
exenatide, 5ug, bid, 3months
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
5ug bid,Subcutaneous injection
Primary Outcome Measure Information:
Title
Dual energy X-ray absorptiometry
Description
fat distribution
Time Frame
3 month
Secondary Outcome Measure Information:
Title
lab testing
Description
inflammation
Time Frame
3 month
Other Pre-specified Outcome Measures:
Title
lab testing
Description
liver function
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of overweight and type 2 diabetes mellitus Exclusion Criteria: Poor body condition (severe liver and kidney dysfunction) Unknown causes of pancreatitis, chronic pancreatitis, pancreatic resection, stomach operation, malignant tumor, previous use of systemic corticosteroids (local or inhalation of exceptions) heart function or niacin, incomplete serious endocrine disease genetic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Jie
Phone
13916674766
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qu Shen
Organizational Affiliation
Shang Tenth People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Tenth People' Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28376799
Citation
Wang X, Chen J, Li L, Zhu CL, Gao J, Rampersad S, Bu L, Qu S. New association of bone morphogenetic protein 4 concentrations with fat distribution in obesity and Exenatide intervention on it. Lipids Health Dis. 2017 Apr 4;16(1):70. doi: 10.1186/s12944-017-0462-1.
Results Reference
derived

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Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status

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