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Degradation of the Anorexic Hormone Peptide YY

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ClinicalTrials.gov Identifier: NCT02493959
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: PYY1-36 infusion Biological: PYY1-36 + sitagliptin Biological: PYY3-36 infusion Biological: placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Degradation of the Anorexic Hormone Peptide YY
Study Start Date : May 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. PYY3-34 concentration [ Time Frame: 0-240 min ]
  2. Half-lives of PYY1-36 and PYY3-36 [ Time Frame: 0-240 min ]

Other Outcome Measures:
  1. Appetite and nausea scores [ Time Frame: 0-240 min ]
    Between infusion differences in VAS scores

  2. Blood pressure [ Time Frame: 0-240 min ]
    Between infusion differences in blood pressure

  3. Blood glucose [ Time Frame: 0-240 min ]
    Between infusion differences in blood glucose

  4. Heart rate [ Time Frame: 0-240 min ]
    Between infusion differences in heart rate



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493959


Locations
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Denmark
Department of Endocrinology, Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen

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Responsible Party: Kirstine Nyvold Bojsen-Moeller, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02493959     History of Changes
Other Study ID Numbers: STKBM-PI14
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015
Keywords provided by Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital:
PYY
Degradation
kinetics
men
Additional relevant MeSH terms:
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Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms
Sitagliptin Phosphate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action