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Completed

NCT Number: NCT02493959

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.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Endocrinology, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PYY1-36 infusion

Biological

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

PYY1-36 + sitagliptin

Biological

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

Biological

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

Placebo

Biological

Infusion of saline for 2 hrs.

Primary outcomes

  1. PYY3-34 concentration

    Time frame: 0-240 min

  2. Half-lives of PYY1-36 and PYY3-36

    Time frame: 0-240 min

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2015
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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