NCT00551343

Brief Summary

The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety hormones in patients with Prader-Willi Syndrome (genetic defect causing 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 not_applicable

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 7, 2020

Status Verified

October 1, 2007

Enrollment Period

11 months

First QC Date

October 29, 2007

Last Update Submit

July 3, 2020

Conditions

Prader-Willi Syndrome

Outcome Measures

Primary Outcomes (1)

  • satiety hormones

    1 day

Secondary Outcomes (1)

  • appetite (visual analogue scale) insulin secretion

    1 day

Study Arms (2)

PWS

OTHER
Drug: Exenatide

Controls

OTHER
Drug: Exenatide

Interventions

ExenatideDRUG

10ug Exenatide single s.c. injection

ControlsPWS

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • see below

You may not qualify if:

  • Diabetes mellitus, acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Garvan Institute of Medical Research

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Prader-Willi Syndrome

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Lesley V Campbell, Prof

    Garvan Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 30, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 7, 2020

Record last verified: 2007-10

Locations

AU(1)