PhysiologyPhase 1GIP-GLP-gasNCT01079624
GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose
A Phase 1 study testing Glucose-insulinotropic peptide, Glucagon-like peptide-1 in people with Physiology and Gastroenterology, run by Uppsala University at 1 site in Sweden.
Trial summary
Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiology, Gastroenterology, Endocrinology
- What is being tested?
- Glucose-insulinotropic peptide, Glucagon-like peptide-1
- 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 siteSweden
- Study dates
- Aug 2006to Nov 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- 18-50 years old;
- otherwise healthy and HIV and HCB, HCV negative
Who cannot join
- Age >50,
- all types of diseases and drug users.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose Homeostasis
Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.
Read the detailed description
Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under simultaneous gastric emptying study and appetite questionnaires and blood sampling for analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as well as those administered, GIP and GLP-1.
- Conditions
- Physiology, Gastroenterology, Endocrinology
- Being tested
- Glucose-insulinotropic peptide, Glucagon-like peptide-1
- Keywords
- Incretin hormones, Glucose-insulinotropic peptide, Glucagon-like peptide-1, Gastric emptying, Appetite, Glucose disposal, Gut hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-insulinotropic peptide, Glucagon-like peptide-1Other
Also called GIP, GLP-1, Saline
GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min
| Study group | Role | What they receive |
|---|---|---|
| GIP two doses and GLP-1 one dose | Experimental | Intervention with infusion of GIP or GLP-1 intravenously Receives: Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1 |
| Saline infusion | Placebo comparator | Control Receives: Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying rate
Measured: 2005-2006
Secondary outcomes (1)
Plasma glucose, insulin release, appetite
Measured: 2005-2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startAug 2006
- Primary completionJan 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiologyStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, University of Copenhagen
- Investigators
- Per M Hellstrom, MD, PhD, Principal investigator, Karolinska Institutet, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079624
- Sponsor's protocol ID
- GIP/GLP-gastric empt-APP-hor
- Other IDs
- K2010-55X -07916-24-3
- Acronym
- GIP-GLP-gas
- Status last verified
- Jul 2009
- First submitted
- 2 Mar 2010
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose Homeostasis
- ClinicalTrials.gov ID
- NCT01079624
- Acronym / sponsor ID
- GIP-GLP-gas / GIP/GLP-gastric empt-APP-hor
- Conditions
- Physiology, Gastroenterology, Endocrinology
- Keywords
- Incretin hormones, Glucose-insulinotropic peptide, Glucagon-like peptide-1, Gastric emptying, Appetite, Glucose disposal, Gut hormones
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, University of Copenhagen
- Study start
- Aug 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Mar 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.
Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.
Detailed description
Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under simultaneous gastric emptying study and appetite questionnaires and blood sampling for analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as well as those administered, GIP and GLP-1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIP two doses and GLP-1 one dose | Experimental | Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1Intervention with infusion of GIP or GLP-1 intravenously |
| Saline infusion | Placebo comparator | Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1Control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women
- 18-50 years old;
- otherwise healthy and HIV and HCB, HCV negative
Key exclusion criteria (2 listed)
- Age >50,
- all types of diseases and drug users.
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 |
|---|---|---|
| Glucose-insulinotropic peptide, Glucagon-like peptide-1Also: GIP, GLP-1, SalineGIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min | Other | GIP two doses and GLP-1 one dose, Saline infusion |
Primary outcome
Gastric emptying rate
Time frame: 2005-2006
1 secondary outcome
Plasma glucose, insulin release, appetite
Time frame: 2005-2006
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 3 Mar 2010.
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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.
Per M Hellstrom, MD, PhD principal investigator
Karolinska Institutet, Uppsala University
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 Glucose-insulinotropic peptide, Glucagon-like peptide-1 in people with Physiology and Gastroenterology, run by Uppsala University at 1 site in Sweden.
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 2 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 3 Mar 2010. 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 Sweden. 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?
Gastric emptying rate (time frame: 2005-2006). 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 3 Mar 2010.