NCT02493959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 2, 2015

Last Update Submit

July 9, 2015

Conditions

Healthy

Keywords

PYYDegradationkineticsmen

Outcome Measures

Primary Outcomes (2)

  • PYY3-34 concentration

    0-240 min

  • Half-lives of PYY1-36 and PYY3-36

    0-240 min

Other Outcomes (4)

  • Appetite and nausea scores

    0-240 min

  • Blood pressure

    0-240 min

  • Blood glucose

    0-240 min

  • +1 more other outcomes

Study Arms (1)

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 infusionBiological: PYY1-36 + sitagliptinBiological: PYY3-36 infusionBiological: placebo

Interventions

PYY1-36 infusionBIOLOGICAL

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

PYY infusion
PYY1-36 + sitagliptinBIOLOGICAL

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.

PYY infusion
PYY3-36 infusionBIOLOGICAL

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

PYY infusion
placeboBIOLOGICAL

Infusion of saline for 2 hrs.

PYY infusion

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Normal BMI (18.5-25kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 10, 2015

Study Start

May 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

DK(1)