ObesityINGEAR-1NCT00940134
Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.
A study testing PYY 3-36, GLP-1 and saline infusion in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- PYY 3-36, GLP-1 and saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jan 2012
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men age 18-50 years
- BMI ≥30
- healthy
Who cannot join
- Diabetes mellitus
- psychological illness
- on special diets (eg vegetarian, Atkins)
- weight change of >3kg within the 2 months prior to screening
- Hypothalamic or genetic aetiology of obesity
- diagnosed cancer
Show all 15Show fewer
- chronic illness or disease
- Eating disorder (anorexia or bulimia)
- smoking
- substance abuse
- Use of any prescription or over the counter medication that can affect metabolism
- Excessive intake of alcohol (>7 drinks/week)
- Excessive intake of caffeine (>300 mg/day)
- High level of physical activity (>10 hours/week)
- Lack of desire or willingness to take part in and follow study protocol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, 1958
About this study
Official title: INGEAR-1: Effects of INtravenous Infusions of PYY3-36 and GLP-1, as Monoinfusion and in Combination, on ad Libitum Energy Intake, Appetite Sensation, and Energy Expenditure in Healthy Obese Subjects.
The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.
- Conditions
- Obesity
- Being tested
- PYY 3-36, GLP-1, saline infusion
- Keywords
- obesity, energy expenditure, incretins, appetite regulation, GLP-1, PYY, ad libitum energy intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYY 3-36Biological
0.8 pmol/kg/min x 3 hours
GLP-1Biological
1.0 pmol/kg/min x 3 hours
saline infusionBiological
saline infusion x 3 hours
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Study participants will receive a 3 hour IV infusion of saline while fasting. Receives: Biological: saline infusion |
| PYY3-36 + GLP-1 | Experimental | Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting. Receives: Biological: PYY 3-36; Biological: GLP-1 |
| GLP-1 | Active comparator | Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting. Receives: Biological: GLP-1 |
| PYY3-36 | Active comparator | Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting. Receives: Biological: PYY 3-36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum energy intake
Measured: Immediately following 3h IV infusion
Secondary outcomes (4)
Energy expenditure (ventilated hood technique).
Measured: During 3h IV infusion
Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin
Measured: Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion
Appetite sensation by visual analog scale
Measured: Every 30 minutes during 3h IV infusion
Gastric emptying (paracetamol)
Measured: At time=15, 30, 60, 90, 120, 180 mins during IV infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Nikolaj T Gregersen, MSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940134
- Sponsor's protocol ID
- B262
- Acronym
- INGEAR-1
- Status last verified
- Jun 2012
- First submitted
- 14 Jul 2009
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt JB, Gregersen NT, Pedersen SD, Arentoft JL, Ritz C, Schwartz TW, Holst JJ, Astrup A, Sjodin A. Effects of PYY3-36 and GLP-1 on energy intake, energy expenditure, and appetite in overweight men. Am J Physiol Endocrinol Metab. 2014 Jun 1;306(11):E1248-56. doi: 10.1152/ajpendo.00569.2013. Epub 2014 Apr 15.
PubMed 24735885
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INGEAR-1: Effects of INtravenous Infusions of PYY3-36 and GLP-1, as Monoinfusion and in Combination, on ad Libitum Energy Intake, Appetite Sensation, and Energy Expenditure in Healthy Obese Subjects.
- ClinicalTrials.gov ID
- NCT00940134
- Acronym / sponsor ID
- INGEAR-1 / B262
- Conditions
- Obesity
- Keywords
- obesity, energy expenditure, incretins, appetite regulation, GLP-1, PYY, ad libitum energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Jul 2009 (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 purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Biological: saline infusionStudy participants will receive a 3 hour IV infusion of saline while fasting. |
| PYY3-36 + GLP-1 | Experimental | Biological: PYY 3-36, Biological: GLP-1Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting. |
| GLP-1 | Active comparator | Biological: GLP-1Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting. |
| PYY3-36 | Active comparator | Biological: PYY 3-36Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men age 18-50 years
- BMI ≥30
- healthy
Key exclusion criteria (15 listed)
- Diabetes mellitus
- psychological illness
- on special diets (eg vegetarian, Atkins)
- weight change of >3kg within the 2 months prior to screening
- Hypothalamic or genetic aetiology of obesity
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 |
|---|---|---|
| PYY 3-360.8 pmol/kg/min x 3 hours | Biological | PYY3-36, PYY3-36 + GLP-1 |
| GLP-11.0 pmol/kg/min x 3 hours | Biological | GLP-1, PYY3-36 + GLP-1 |
| saline infusionsaline infusion x 3 hours | Biological | placebo |
Primary outcome
Ad libitum energy intake
Time frame: Immediately following 3h IV infusion
4 secondary outcomes
Energy expenditure (ventilated hood technique).
Time frame: During 3h IV infusion
Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin
Time frame: Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion
Appetite sensation by visual analog scale
Time frame: Every 30 minutes during 3h IV infusion
Gastric emptying (paracetamol)
Time frame: At time=15, 30, 60, 90, 120, 180 mins during IV infusion
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 15 Jun 2012.
- Derived from this study: PubMed 24735885Schmidt JB, Gregersen NT, Pedersen SD, Arentoft JL, Ritz C, Schwartz TW, Holst JJ, Astrup A, Sjodin A. Effects of PYY3-36 and GLP-1 on energy intake, energy expenditure, and appetite in overweight men. Am J Physiol Endocrinol Metab. 2014 Jun 1;306(11):E1248-56. doi: 10.1152/ajpendo.00569.2013. Epub 2014 Apr 15.
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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.
Nikolaj T Gregersen, MSc principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PYY 3-36, GLP-1 and saline infusion in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 15 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Ad libitum energy intake (time frame: Immediately following 3h IV infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940134, which also lists 1 linked publication.
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 15 Jun 2012.