Incretin ActionNCT01232244
Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.
An observational study of Incretin Action and Obesity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Incretin Action, Obesity
- What is being tested?
- GLP-1 infusion, Glucagon infusion and Oxyntomodulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Jan 2012
- Phase
- Observational
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy young males
Who may be able to join
- Normal fasting plasma glucose
- Normal glucose tolerance
- Normal haemoglobin levels
- Informed content
Who cannot join
- Diabetes
- Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
- 1st degree relatives with diabetes
- Obesity (BMI > 30)
- Inflammatory bowels disease
- Bowels surgery
Show all 9Show fewer
- Nephropathy
- Liver disease
- Medication which cannot be on hold for 24h
Trial locations and contacts
1 site in 1 country.
About this study
Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss.
Therefore we want to investigate mechanistic relations between the three hormones.
- Conditions
- Incretin Action, Obesity
- Being tested
- GLP-1 infusion, Glucagon infusion, Oxyntomodulin infusion, GLP-1 and glucagon infusion, Placebo
- Keywords
- Incretin hormones, Glucagon, Satiety, Hunger, Energy expenditure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 infusionOther
1 pmol/kg/min
Glucagon infusionOther
3ng/kg/min
Oxyntomodulin infusionOther
3 pmol/kg/min
GLP-1 and glucagon infusionOther
1 pmol/kg/min 3 ng/kg/min
PlaceboOther
NaCl 9 g/L infusion
| Study group | Role | What they receive |
|---|---|---|
| Healthy young males | Not described Receives: Other: GLP-1 infusion; Other: Glucagon infusion; Other: Oxyntomodulin infusion; Other: GLP-1 and glucagon infusion; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Assessed by the acetaminophen - method
Measured: 4 h
Satiety
Assessed by VAS
Measured: 4 h
Hunger
Assessed by an ad'libitum meal
Measured: 4 h
basal energy expenditure
Assessed by indirect calorimetry
Measured: 2 x 30min
Secondary outcomes (4)
GLP-1
Measured: 4 h
Oxyntomodulin
Measured: 4 h
Glucagon
Measured: 4 h
GIP
Measured: 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- 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 Incretin ActionStudies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
- Investigators
- Jonatan I Bagger, MD, Principal investigator, Gentofte University Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232244
- Sponsor's protocol ID
- OXMDissek
- Status last verified
- Dec 2013
- First submitted
- 1 Nov 2010
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bagger JI, Holst JJ, Hartmann B, Andersen B, Knop FK, Vilsboll T. Effect of Oxyntomodulin, Glucagon, GLP-1, and Combined Glucagon +GLP-1 Infusion on Food Intake, Appetite, and Resting Energy Expenditure. J Clin Endocrinol Metab. 2015 Dec;100(12):4541-52. doi: 10.1210/jc.2015-2335. Epub 2015 Oct 7.
PubMed 26445112
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.
- ClinicalTrials.gov ID
- NCT01232244
- Acronym / sponsor ID
- OXMDissek
- Conditions
- Incretin Action, Obesity
- Keywords
- Incretin hormones, Glucagon, Satiety, Hunger, Energy expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Nov 2010 (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.
Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss.
Therefore we want to investigate mechanistic relations between the three hormones.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young males | – | Other: GLP-1 infusion, Other: Glucagon infusion, Other: Oxyntomodulin infusion, Other: GLP-1 and glucagon infusion, Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy young males
Key inclusion criteria (4 listed)
- Normal fasting plasma glucose
- Normal glucose tolerance
- Normal haemoglobin levels
- Informed content
Key exclusion criteria (9 listed)
- Diabetes
- Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
- 1st degree relatives with diabetes
- Obesity (BMI > 30)
- Inflammatory bowels disease
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 |
|---|---|---|
| GLP-1 infusion1 pmol/kg/min | Other | Healthy young males |
| Glucagon infusion3ng/kg/min | Other | Healthy young males |
| Oxyntomodulin infusion3 pmol/kg/min | Other | Healthy young males |
| GLP-1 and glucagon infusion1 pmol/kg/min 3 ng/kg/min | Other | Healthy young males |
| PlaceboNaCl 9 g/L infusion | Other | Healthy young males |
Primary outcome
Gastric emptying
Time frame: 4 h
Assessed by the acetaminophen - method
Satiety
Time frame: 4 h
Assessed by VAS
Hunger
Time frame: 4 h
Assessed by an ad'libitum meal
basal energy expenditure
Time frame: 2 x 30min
Assessed by indirect calorimetry
4 secondary outcomes
GLP-1
Time frame: 4 h
Oxyntomodulin
Time frame: 4 h
Glucagon
Time frame: 4 h
GIP
Time frame: 4 h
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 10 Dec 2013.
- Derived from this study: PubMed 26445112Bagger JI, Holst JJ, Hartmann B, Andersen B, Knop FK, Vilsboll T. Effect of Oxyntomodulin, Glucagon, GLP-1, and Combined Glucagon +GLP-1 Infusion on Food Intake, Appetite, and Resting Energy Expenditure. J Clin Endocrinol Metab. 2015 Dec;100(12):4541-52. doi: 10.1210/jc.2015-2335. Epub 2015 Oct 7.
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.
Jonatan I Bagger, MD principal investigator
Gentofte University Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incretin Action and Obesity, run by University Hospital, Gentofte, 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 4 inclusion and 9 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 10 Dec 2013. 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. 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?
Gastric emptying (time frame: 4 h). The study lists 4 primary outcomes in all. 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 NCT01232244, 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 10 Dec 2013.