Effects of GLP-1 Receptor Agonist on Fat Redistribution a... | NCT02118376

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

NCT02118376

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Apr 21, 2014Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Exenatide

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Dec 20, 2013

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2014

Last Update Posted Date

Apr 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exenatide	Experimental	exenatide, 5ug, bid, 3months	Drug: Exenatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exenatide	Drug	5ug bid,Subcutaneous injection	exenatide	Byetta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dual energy X-ray absorptiometry	fat distribution	3 month

Secondary Outcomes

Measure	Description	Time Frame
lab testing	inflammation	3 month

Other Outcomes

Measure	Description	Time Frame
lab testing	liver function	3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu Jie	Contact	13916674766

Overall Officials

Name	Affiliation	Role
Qu Shen	Shang Tenth People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Tenth People' Hospital		Shanghai	Shanghai Municipality	200072	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28376799	Derived	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.

ID	Term
D009765	Obesity
D007249	Inflammation

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures