Gut Derived Hormones, Body Composition and Metabolism in... | NCT00551343

Studies
Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome

NCT00551343

Sponsor

Garvan Institute of Medical Research

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Prader-Willi Syndrome

Interventions

Exenatide

Countries

Australia

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

ID	Type	Description	Link
X07-0178

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Oct 29, 2007

First Submission Date that Met QC Criteria

Oct 29, 2007

First Posted Date

Oct 30, 2007Estimated

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

Jul 3, 2020

Last Update Posted Date

Jul 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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).

Detailed Description

Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity. Hyperphagia is the main barrier to independent living in adults with PWS, and hitherto behavioural restraints and environmental modification are the only effective management measure. The emerging costs for professional care are immense. Thus, there is an urgent need for treatment which reduce appetite and food intake in this patient group. Agonists of the gut derived hormone GLP-1 which reduces food intake and causes weight loss due to slowed gastric emptying and through direct central effects. The aim of this pilot drug trial is to analyse the effect of a GLP-1 agonist on appetite regulating hormones, insulin secretion and energy expenditure before and after a meal.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PWS	Other		Drug: Exenatide
Controls	Other		Drug: Exenatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exenatide	Drug	10ug Exenatide single s.c. injection	Controls PWS

Measure	Description	Time Frame
satiety hormones		1 day

Measure	Description	Time Frame
appetite (visual analogue scale) insulin secretion		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

see below

Exclusion Criteria:

Diabetes mellitus, acute infections

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lesley V Campbell, Prof	Garvan Institute of Medical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Garvan Institute of Medical Research		Sydney	New South Wales	2010	Australia

Condition Browse Module

MeSH Terms

ID	Term
D011218	Prader-Willi Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077270	Exenatide

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided