Appetite and General Nutritional DisordersPhase 1NCT01900340
Intestinal Glucagon-like Peptide-1 (GLP-1) and the Physiological Role in Eating in Humans
A Phase 1 study testing Saline, Exendin 9-39 and Exendin(9-39) plus ID nutrient in people with Appetite and General Nutritional Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim is to further establish a physiological role for GLP-1 as an endogenous satiety signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite and General Nutritional Disorders
- What is being tested?
- Saline, Exendin 9-39 and Exendin(9-39) plus ID nutrient
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject with a BMI of 19-25 m2/kg
- Stable body weight for at least three months
- Normal eating habits
- Age between 18 and 45 years
- Sufficient understanding of the German language
- Subjects understand the procedures and the risks associated with the study
- Participants must be willing to adhere to the protocol and sign the consent form
Who cannot join
- Participation in another clinical trial (currently or within the last 30 days)
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values
- History of gastrointestinal disorders
- Food allergies
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to further establish a physiological role for GLP-1 as an endogenous satiety signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects.
Read the detailed description
Understanding the exact mechanisms by which GLP-1 inhibits eating can be crucial in order to convert its anorectic action into useful, safe and effective drugs. So far, it is however not clear to what extent GLP-1 is a hormonal regulator of eating or whether the observed effects are rather a pharmacological phenomenon. By applying classical algorithms from endocrinology several criteria must be fulfilled before a hormone can be considered an endogenous physiological satiety signal. One is that exogenous administration of a selective antagonist should prevent the eating-inhibitory effect of GLP-1. At present, cholecystokinin (CCK) is the only peptide in humans identified to fit these criteria. For intestinal GLP-1, it has not been investigated whether a specific GLP-1 receptor antagonist can block the eating-inhibitory effect in humans. The availability of a specific GLP-1 receptor antagonist, exendin (9-39), now makes it possible to further investigate this pathway. Exendin (9-39), is a powerful tool available for human use to characterize of endogenous GLP-1 as a physiological regulator of different biological functions. The molecule has been used to document that endogenous GLP-1 is an important incretin hormone and a regulator of antro-pyloro-duodenal motility. The role of endogenous GLP-1 in regulating food intake and appetite has, however, not been investigated before.
- Being tested
- Saline, Exendin 9-39, Exendin(9-39) plus ID nutrient
- Keywords
- GLP-1, satiation peptides, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDietary supplement
Intravenous saline infusion and intraduodenal administration of saline via feeding tube
Exendin 9-39Drug
IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube
SalineDietary supplement
IV saline infusion and intraduodenal administration of nutrients
Exendin(9-39) plus ID nutrientDrug
Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration
| Study group | Role | What they receive |
|---|---|---|
| iv saline, intraduodenal saline | Placebo comparator | intravenous infusion of saline plus intraduodenal administration of saline Receives: Dietary Supplement: Saline |
| IV exendin(9-39) plus intraduodenal (ID) saline | Active comparator | intravenous infusion of exendin(9-39) plus intraduodenal administration of saline Receives: Drug: Exendin 9-39 |
| IV saline, intraduodenal nutrient | Placebo comparator | intravenous infusion of saline plus intraduodenal administration of nutrient Receives: Dietary Supplement: Saline |
| Exendin(9-39) plus ID nutrient | Active comparator | Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration Receives: Drug: Exendin(9-39) plus ID nutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of exendin(9-39)on total calorie intake
Measured: 60 min test meal
Effect of exendin(9-39) on total fluid intake
Measured: 60 min test meal
Effect of exendin(9-39)on meal duration during an ad libitum test meal.
Measured: 60 min test meal
Secondary outcomes (7)
Effect of exendin(9-39)on plasma concentration of glucose
Measured: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of insulin.
Measured: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of glucagon.
Measured: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of GLP-1.
Measured: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of peptide tyrosine tyrosine (PYY).
Measured: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of CCK.
Measured: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of ghrelin.
Measured: 4 hours blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 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 Appetite and General Nutritional DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, University Hospital Basel, Phase 1 Research Unit, Basel Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900340
- Sponsor's protocol ID
- EKBB 25/11
- Status last verified
- Jul 2013
- First submitted
- 3 Apr 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25.
PubMed 24965303
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Glucagon-like Peptide-1 (GLP-1) and the Physiological Role in Eating in Humans
- ClinicalTrials.gov ID
- NCT01900340
- Acronym / sponsor ID
- EKBB 25/11
- Keywords
- GLP-1, satiation peptides, food intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Jul 2013 (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 is to further establish a physiological role for GLP-1 as an endogenous satiety signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects.
Detailed description
Understanding the exact mechanisms by which GLP-1 inhibits eating can be crucial in order to convert its anorectic action into useful, safe and effective drugs. So far, it is however not clear to what extent GLP-1 is a hormonal regulator of eating or whether the observed effects are rather a pharmacological phenomenon. By applying classical algorithms from endocrinology several criteria must be fulfilled before a hormone can be considered an endogenous physiological satiety signal. One is that exogenous administration of a selective antagonist should prevent the eating-inhibitory effect of GLP-1. At present, cholecystokinin (CCK) is the only peptide in humans identified to fit these criteria. For intestinal GLP-1, it has not been investigated whether a specific GLP-1 receptor antagonist can block the eating-inhibitory effect in humans. The availability of a specific GLP-1 receptor antagonist, exendin (9-39), now makes it possible to further investigate this pathway. Exendin (9-39), is a powerful tool available for human use to characterize of endogenous GLP-1 as a physiological regulator of different biological functions. The molecule has been used to document that endogenous GLP-1 is an important incretin hormone and a regulator of antro-pyloro-duodenal motility. The role of endogenous GLP-1 in regulating food intake and appetite has, however, not been investigated before.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iv saline, intraduodenal saline | Placebo comparator | Dietary Supplement: Salineintravenous infusion of saline plus intraduodenal administration of saline |
| IV exendin(9-39) plus intraduodenal (ID) saline | Active comparator | Drug: Exendin 9-39intravenous infusion of exendin(9-39) plus intraduodenal administration of saline |
| IV saline, intraduodenal nutrient | Placebo comparator | Dietary Supplement: Salineintravenous infusion of saline plus intraduodenal administration of nutrient |
| Exendin(9-39) plus ID nutrient | Active comparator | Drug: Exendin(9-39) plus ID nutrientExendin(9-39) as intravenous infusion plus intraduodenal nutrient administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subject with a BMI of 19-25 m2/kg
- Stable body weight for at least three months
- Normal eating habits
- Age between 18 and 45 years
- Sufficient understanding of the German language
Key exclusion criteria (7 listed)
- Participation in another clinical trial (currently or within the last 30 days)
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values
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 |
|---|---|---|
| SalineIntravenous saline infusion and intraduodenal administration of saline via feeding tube | Dietary supplement | iv saline, intraduodenal saline |
| Exendin 9-39IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube | Drug | IV exendin(9-39) plus intraduodenal (ID) saline |
| SalineIV saline infusion and intraduodenal administration of nutrients | Dietary supplement | IV saline, intraduodenal nutrient |
| Exendin(9-39) plus ID nutrientExendin(9-39) as intravenous infusion plus intraduodenal nutrient administration | Drug | Exendin(9-39) plus ID nutrient |
Primary outcome
Effect of exendin(9-39)on total calorie intake
Time frame: 60 min test meal
Effect of exendin(9-39) on total fluid intake
Time frame: 60 min test meal
Effect of exendin(9-39)on meal duration during an ad libitum test meal.
Time frame: 60 min test meal
7 secondary outcomes
Effect of exendin(9-39)on plasma concentration of glucose
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of insulin.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of glucagon.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of GLP-1.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of peptide tyrosine tyrosine (PYY).
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of CCK.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of ghrelin.
Time frame: 4 hours blood sampling
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 16 Jul 2013.
- Derived from this study: PubMed 24965303Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25.
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.
Christoph Beglinger, MD principal investigator
University Hospital Basel, Phase 1 Research Unit, Basel Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saline, Exendin 9-39 and Exendin(9-39) plus ID nutrient in people with Appetite and General Nutritional Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 inclusion and 7 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 16 Jul 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 Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of exendin(9-39)on total calorie intake (time frame: 60 min test meal). The study lists 3 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 NCT01900340, 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 16 Jul 2013.