NCT00259233

Brief Summary

12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses PYY3-36 on 5 different test days within one week. The patients will be tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
Last Updated

January 21, 2009

Status Verified

April 1, 2007

First QC Date

November 25, 2005

Last Update Submit

January 20, 2009

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • appetite

  • energy intake

Secondary Outcomes (2)

  • Plasma PYY profile

  • Blood pressure

Interventions

peripheral Peptide YY administrationDRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2)
  • Body weight fluctuations \< 5 kg over the past 2 months.
  • Blood pressure normal to mildly hypertensive(\<159/99 mm Hg)
  • Non-elite athletes and not planning to change physical activity during the study.

You may not qualify if:

  • Any physiological or psychological illnesses that could influence the study results.
  • Regular use of medicine.
  • Smoking defined as \<1 cigarette per day.
  • Substance abuse or dependence.
  • Blood donation within the past 3 months before entering the study.
  • Drinking \>21 alcoholic units/week.
  • Food allergies.
  • Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arne Astrup, Professor

    Department of Human Nutrition, RVAU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2005

First Posted

November 29, 2005

Study Start

March 1, 2005

Study Completion

May 1, 2005

Last Updated

January 21, 2009

Record last verified: 2007-04