Degradation of the Anorexic Hormone Peptide YY

Healthy Clinical Trial

Official title:

Degradation of the Anorexic Hormone Peptide YY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493959
• Other study ID #: STKBM-PI14
• Status: Completed
• Phase: Phase 0
• First received: July 2, 2015
• Last updated: July 9, 2015
• Start date: May 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• PYY1-36 infusion
Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.
• 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.
• PYY3-36 infusion
0.8 pmol/kg/min infusion of PYY3-36.
• placebo
Infusion of saline for 2 hrs.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Hvidovre Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appetite and nausea scores	Between infusion differences in VAS scores	0-240 min	No
Other	Blood pressure	Between infusion differences in blood pressure	0-240 min	No
Other	Blood glucose	Between infusion differences in blood glucose	0-240 min	No
Other	Heart rate	Between infusion differences in heart rate	0-240 min	No
Primary	PYY3-34 concentration		0-240 min	No
Primary	Half-lives of PYY1-36 and PYY3-36		0-240 min	No