Healthy SubjectsNCT00999271
Glucose-dependent Insulinotropic Polypeptide (GIP) and Lipid Metabolism
An observational study of Healthy Subjects, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in combination with insulin affect gastric emptying (GE), appetite, energy intake, energy expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol in man. 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
- Healthy Subjects
- What is being tested?
- Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Sep 2009
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Informed oral and written consent
- Caucasians over the age of 18 years
- Normal 75 g oral glucose tolerance test (OGTT)
- Normal blood haemoglobin concentration
- Normal plasma lipid profile
Who cannot join
- First-degree relatives with diabetes and familial hypertriglyceridemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On the Role of Glucose-dependent Insulinotropic Polypeptide, GIP, in Postprandial Metabolism in Humans
The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in combination with insulin affect gastric emptying (GE), appetite, energy intake, energy expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol in man.
- Conditions
- Healthy Subjects
- Being tested
- Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)
- Keywords
- Glucose-dependent insulinotropic polypeptide, gastric emptying, appetite, energy intake, lipid metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)Other
two different dosages:
- 0.8 pmol/kg/min
- 1.5 pmol/kg/min for 300 minutes
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 30 healthy subjects without family history of diabetes or gastrointestinal disease, a normal oral glucose tolerance test (OGTT) and no intake of medicine Receives: Other: Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Observational model
- Case-control
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999271
- Sponsor's protocol ID
- HD-2009-0025
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 21 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On the Role of Glucose-dependent Insulinotropic Polypeptide, GIP, in Postprandial Metabolism in Humans
- ClinicalTrials.gov ID
- NCT00999271
- Acronym / sponsor ID
- HD-2009-0025
- Conditions
- Healthy Subjects
- Keywords
- Glucose-dependent insulinotropic polypeptide, gastric emptying, appetite, energy intake, lipid metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Oct 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 aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in combination with insulin affect gastric emptying (GE), appetite, energy intake, energy expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol in man.
Study design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)30 healthy subjects without family history of diabetes or gastrointestinal disease, a normal oral glucose tolerance test (OGTT) and no intake of medicine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- Informed oral and written consent
- Caucasians over the age of 18 years
- Normal 75 g oral glucose tolerance test (OGTT)
- Normal blood haemoglobin concentration
- Normal plasma lipid profile
Key exclusion criteria (1 listed)
- First-degree relatives with diabetes and familial hypertriglyceridemia
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 |
|---|---|---|
| Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)two different dosages: * 0.8 pmol/kg/min * 1.5 pmol/kg/min for 300 minutes | Other | Healthy subjects |
Primary outcome
Not reported in the source record.
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 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy Subjects, run by Hvidovre University Hospital 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 5 inclusion and 1 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 Oct 2009. 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.
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 Oct 2009.