Type 2 Diabetes MellitusEarly Phase 1NCT01453842
Diet Oil Induced Stimulation of GLP-1
A Early Phase 1 study testing Diet oil, Olive oil and Carrot in people with Type 2 Diabetes Mellitus, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Diet oil, Olive oil and Carrot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Mar 2012
- Phase
- Early 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus according to the WHO criteria
- caucasians
- age above 18 years
- BMI 20-30
Who cannot join
- kidney disease
- liver disease
- retinopathy
- anaemia
- use of insulin
- use of GLP-1 analogues
- use of DPP-4 inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone.
Read the detailed description
Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone. The aim of the study is to elucidate the effect of 2-OG, 'diet oil' on GLP-1 secretion in patients with type 2 diabetes and to explain the mechanism behind the known stimulation of GLP-1 release by dietary fat.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diet oil, Olive oil, Carrot
- Keywords
- Glucagon-like peptide-1, Glucose-dependant insulinotropic polypeptide, Glucagon, Peptide PYY, 2-oleyl glycerol
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet oilDietary supplement
Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol
Olive oilDietary supplement
Carrot and olive oil and 1½ g of paracetamol
CarrotDietary supplement
Carrot and 1½ g of paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Diet oil | Experimental | Not described Receives: Dietary Supplement: Diet oil |
| Olive oil | Active comparator | Not described Receives: Dietary Supplement: Olive oil |
| Carrot | Placebo comparator | Not described Receives: Dietary Supplement: Carrot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma GLP-1
Glp-1 response is measured during and three hours after ingestion of the different mealtest
Measured: 3 hours
Secondary outcomes (6)
Plasma insulin
Plasma insulin is measured during and 3 hours after mealtest
Measured: 3 hours
Plasma glucose
Plasma glucose is measured during and 3 hours after meal test
Measured: 3 hours
Plasma GIP
Plasma GIP is measured during and 3 hours after meal test
Measured: 3 hours
Plasma glucagon
Plasma glucagon is measured during and 3 hours after meal test
Measured: 3 hours
Plasma PYY
Plasma PYY is measured during and 3 hours after meal test
Measured: 3 hours
Plasma paracetamol
Plasma paracetamol is measured during and 3 hours after meal test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Bagge Hansen, University of Copenhagen
- Investigators
- Katrine B Hansen, MD, Study chair, University of openhagenJens J Holst, Professor, Study chair, University of CopenhagenHarald S Hansen, Professor, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453842
- Sponsor's protocol ID
- Diet oil
- Status last verified
- Dec 2014
- First submitted
- 13 Oct 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Oil Induced Stimulation of GLP-1
- ClinicalTrials.gov ID
- NCT01453842
- Acronym / sponsor ID
- Diet oil
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glucagon-like peptide-1, Glucose-dependant insulinotropic polypeptide, Glucagon, Peptide PYY, 2-oleyl glycerol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Oct 2011 (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.
Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone.
Detailed description
Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone. The aim of the study is to elucidate the effect of 2-OG, 'diet oil' on GLP-1 secretion in patients with type 2 diabetes and to explain the mechanism behind the known stimulation of GLP-1 release by dietary fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet oil | Experimental | Dietary Supplement: Diet oil |
| Olive oil | Active comparator | Dietary Supplement: Olive oil |
| Carrot | Placebo comparator | Dietary Supplement: Carrot |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes mellitus according to the WHO criteria
- caucasians
- age above 18 years
- BMI 20-30
Key exclusion criteria (7 listed)
- kidney disease
- liver disease
- retinopathy
- anaemia
- use of insulin
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 |
|---|---|---|
| Diet oilCarrot and diet oil (containing 2-OG) and 1½ g of paracetamol | Dietary supplement | Diet oil |
| Olive oilCarrot and olive oil and 1½ g of paracetamol | Dietary supplement | Olive oil |
| CarrotCarrot and 1½ g of paracetamol | Dietary supplement | Carrot |
Primary outcome
Plasma GLP-1
Time frame: 3 hours
Glp-1 response is measured during and three hours after ingestion of the different mealtest
6 secondary outcomes
Plasma insulin
Time frame: 3 hours
Plasma glucose
Time frame: 3 hours
Plasma GIP
Time frame: 3 hours
Plasma glucagon
Time frame: 3 hours
Plasma PYY
Time frame: 3 hours
Plasma paracetamol
Time frame: 3 hours
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 2 Dec 2014.
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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.
Katrine B Hansen, MD study chair
University of openhagen
Jens J Holst, Professor study chair
University of Copenhagen
Harald S Hansen, Professor study chair
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 Early Phase 1 study testing Diet oil, Olive oil and Carrot in people with Type 2 Diabetes Mellitus, 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 4 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 2 Dec 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Plasma GLP-1 (time frame: 3 hours). 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 2 Dec 2014.