ObesityNCT00259246
The Role of Peptide YY (PYY)Infusions in Inhibiting Food Intake.
A study testing Peptide YY infusion in people with Obesity, run by University of Copenhagen.
Trial summary
The aim of the study is to compare fasting and postprandial PYY levels between overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36 and to evaluate the efects on appetite, energy intake and energy expenditure. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Peptide YY infusion
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Fasting and Postprandial Response After Infusion of Saline, PYY1-36 and PYY3-36 and Effects on Appetite, Energy Intake and Energy Expenditure in Overweight/Obese Compared to Normalweight Subjects
The aim of the study is to compare fasting and postprandial PYY levels between overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36 and to evaluate the efects on appetite, energy intake and energy expenditure.
Read the detailed description
The study is a randomised dobbelblinded placebo controlled study with 24 male subjects ( 12 lean and 12 overweight/obese subjects). VAS scores are used to assess appetite and two ad libitum meals are served in the hours following the infusion. Energy expenditure is measured by ventilated hood system and blood is sampled during part of the study day.
- Conditions
- Obesity
- Being tested
- Peptide YY infusion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide YY infusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite
Energy intake
Secondary outcomes (3)
Energy expenditure and substrate oxidation
Blood parameters
Blood pressure and heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startJun 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- EC-FP6 (contract number: LHM-CT-2003-503041), Aditech Pharma AB
- Investigators
- Arne Astrup, Professor, Principal investigator, Department of Human Nutrition, RVAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259246
- Sponsor's protocol ID
- B208,1
- Status last verified
- Apr 2005
- First submitted
- 25 Nov 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting and Postprandial Response After Infusion of Saline, PYY1-36 and PYY3-36 and Effects on Appetite, Energy Intake and Energy Expenditure in Overweight/Obese Compared to Normalweight Subjects
- ClinicalTrials.gov ID
- NCT00259246
- Acronym / sponsor ID
- B208,1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- EC-FP6 (contract number: LHM-CT-2003-503041), Aditech Pharma AB
- Study start
- Jun 2004
- Study completion
- Nov 2005
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare fasting and postprandial PYY levels between overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36 and to evaluate the efects on appetite, energy intake and energy expenditure.
Detailed description
The study is a randomised dobbelblinded placebo controlled study with 24 male subjects ( 12 lean and 12 overweight/obese subjects). VAS scores are used to assess appetite and two ad libitum meals are served in the hours following the infusion. Energy expenditure is measured by ventilated hood system and blood is sampled during part of the study day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide YY infusion | Drug | – |
Primary outcome
Appetite
Energy intake
3 secondary outcomes
Energy expenditure and substrate oxidation
Blood parameters
Blood pressure and heart rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Professor principal investigator
Department of Human Nutrition, RVAU
Questions about this trial
What is this clinical trial studying?
A study testing Peptide YY infusion in people with Obesity, run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.