NCT02118376

Brief Summary

GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

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
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 21, 2014

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

December 20, 2013

Last Update Submit

April 16, 2014

Conditions

Obesity

Keywords

obesity; fat distribution; inflammation

Outcome Measures

Primary Outcomes (1)

  • Dual energy X-ray absorptiometry

    fat distribution

    3 month

Secondary Outcomes (1)

  • lab testing

    3 month

Other Outcomes (1)

  • lab testing

    3 months

Study Arms (1)

exenatide

EXPERIMENTAL

exenatide, 5ug, bid, 3months

Drug: Exenatide

Interventions

ExenatideDRUG

5ug bid,Subcutaneous injection

Also known as: Byetta
exenatide

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of overweight and type 2 diabetes mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

  • 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.

    PMID: 28376799DERIVED

MeSH Terms

Conditions

ObesityInflammation

Interventions

Exenatide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Qu Shen

    Shang Tenth People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Yu Jie

CONTACT

13916674766

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2013

First Posted

April 21, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 21, 2014

Record last verified: 2013-12

Locations

CN(1)