Degradation of the Anorexic Hormone Peptide YY | NCT02493959

Studies
Degradation of the Anorexic Hormone Peptide YY

NCT02493959

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jul 10, 2015Estimated

Enrollment

8Actual

Phase

Early Phase 1

Conditions

Healthy

Interventions

PYY1-36 infusion
PYY1-36 + sitagliptin
PYY3-36 infusion
placebo

Countries

Denmark

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

Jul 2015

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

May 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 9, 2015

First Posted Date

Jul 10, 2015Estimated

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 9, 2015

Last Update Posted Date

Jul 10, 2015Estimated

Name	Class
University of Copenhagen	OTHER

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

Peptide YY (PYY) is a gastrointestinal hormone released from the enteroendocrine cell upon food intake. The N-terminal truncated form, PYY3-36, exerts anorexic effects. In this study we want to investigate the kinetics of PYY1-36 and PYY3-36 and to examine whether a C-terminally degraded metabolite, PYY3-34, is formed after infusion of PYY.

Detailed Description

Not provided

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PYY infusion	Experimental	IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years	Biological: PYY1-36 infusion Biological: PYY1-36 + sitagliptin Biological: PYY3-36 infusion Biological: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PYY1-36 infusion	Biological	Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.	PYY infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PYY3-34 concentration		0-240 min
Half-lives of PYY1-36 and PYY3-36		0-240 min

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Appetite and nausea scores	Between infusion differences in VAS scores	0-240 min
Blood pressure	Between infusion differences in blood pressure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Normal BMI (18.5-25kg/m2)

Exclusion Criteria:

Diabetes Mellitus
Gastric bypass
Non-caucasian
Height changes >3 kg within last two months
Hemoglobin < 7.6 mmol/l
Chronic disease
Smoking
Regularly use of medicine
Drug abuse

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Hvidovre Hospital		Hvidovre		DK-2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D018761	Multiple Endocrine Neoplasia Type 1

Ancestor Terms

ID	Term
D009377	Multiple Endocrine Neoplasia
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided