Degradation of the Anorexic Hormone Peptide YY

NCT ID: NCT02493959

Last Updated: 2015-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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PYY infusion

IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years

Group Type EXPERIMENTAL

PYY1-36 infusion

Intervention Type BIOLOGICAL

Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.

PYY1-36 + sitagliptin

Intervention Type BIOLOGICAL

Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively.

PYY3-36 infusion

Intervention Type BIOLOGICAL

0.8 pmol/kg/min infusion of PYY3-36.

placebo

Intervention Type BIOLOGICAL

Infusion of saline for 2 hrs.

Interventions

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PYY1-36 infusion

Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.

Intervention Type BIOLOGICAL

PYY1-36 + sitagliptin

Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively.

Intervention Type BIOLOGICAL

PYY3-36 infusion

0.8 pmol/kg/min infusion of PYY3-36.

Intervention Type BIOLOGICAL

placebo

Infusion of saline for 2 hrs.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kirstine Nyvold Bojsen-Moeller

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Endocrinology, Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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STKBM-PI14

Identifier Type: -

Identifier Source: org_study_id

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