Degradation of the Anorexic Hormone Peptide YY

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: PYY1-36 infusion; Biological: PYY1-36 + sitagliptin; Biological: PYY3-36 infusion; Biological: placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, DK-2650
    • Department of Endocrinology, Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PYY infusion; IV infusion on 4 separate days of PYY or saline in Healthy, normal-weight men, age 18-50 years	Biological: PYY1-36 infusion; Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.; 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.; Biological: PYY3-36 infusion; 0.8 pmol/kg/min infusion of PYY3-36.; Biological: placebo; Infusion of saline for 2 hrs.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	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	0-240 min
Blood glucose	Between infusion differences in blood glucose	0-240 min
Heart rate	Between infusion differences in heart rate	0-240 min

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: men; PYY; kinetics; Degradation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Anorexia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: STKBM-PI14