Back to resultsDegradation of the Anorexic Hormone Peptide YY
Primary Purpose
Healthy
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
PYY1-36 infusion
PYY1-36 + sitagliptin
PYY3-36 infusion
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring PYY, Degradation, kinetics, men
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
Sites / Locations
- Department of Endocrinology, Hvidovre Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PYY infusion
Arm Description
IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years
Outcomes
Primary Outcome Measures
PYY3-34 concentration
Half-lives of PYY1-36 and PYY3-36
Secondary Outcome Measures
Full Information
NCT ID
NCT02493959
First Posted
July 2, 2015
Last Updated
July 9, 2015
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02493959
Brief Title
Degradation of the Anorexic Hormone Peptide YY
Official Title
Degradation of the Anorexic Hormone Peptide YY
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
PYY, Degradation, kinetics, men
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PYY infusion
Arm Type
Experimental
Arm Description
IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years
Intervention Type
Biological
Intervention Name(s)
PYY1-36 infusion
Intervention Description
Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.
Intervention Type
Biological
Intervention Name(s)
PYY1-36 + sitagliptin
Intervention Description
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
Intervention Name(s)
PYY3-36 infusion
Intervention Description
0.8 pmol/kg/min infusion of PYY3-36.
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Infusion of saline for 2 hrs.
Primary Outcome Measure Information:
Title
PYY3-34 concentration
Time Frame
0-240 min
Title
Half-lives of PYY1-36 and PYY3-36
Time Frame
0-240 min
Other Pre-specified Outcome Measures:
Title
Appetite and nausea scores
Description
Between infusion differences in VAS scores
Time Frame
0-240 min
Title
Blood pressure
Description
Between infusion differences in blood pressure
Time Frame
0-240 min
Title
Blood glucose
Description
Between infusion differences in blood glucose
Time Frame
0-240 min
Title
Heart rate
Description
Between infusion differences in heart rate
Time Frame
0-240 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Endocrinology, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Degradation of the Anorexic Hormone Peptide YY
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