Type 2 DiabetesNCT00612950
Beta-Cell Function After Near-Normalisation of Blood Glucose
A study testing glucagon-like peptide-1,, glucose dependent insulinotropic polypeptide and Saline in people with Type 2 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- glucagon-like peptide-1,, glucose dependent insulinotropic polypeptide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to May 2007
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Type 2 diabetes diagnosed after 30 years of age
- BMI > 25
Who cannot join
- Severe complications to diabetes
- Abnormal liver and kidney function
- Haemoglobin below the lower limit
- Macroalbuminuria
- Systemic disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes
The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- glucagon-like peptide-1,, glucose dependent insulinotropic polypeptide, Saline
- 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.
glucagon-like peptide-1,Drug
GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
glucose dependent insulinotropic polypeptideDrug
continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
SalineDrug
continuous infusion of Saline for 120 min
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Experimental | Not described Receives: Drug: glucagon-like peptide-1, |
| GIP | Experimental | Not described Receives: Drug: glucose dependent insulinotropic polypeptide |
| saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
2.phase insulin response measured as incremental area under the curve from 10-120 minutes
Measured: 2 hours
Secondary outcomes (1)
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startOct 2006
- Primary completionFeb 2007
- Study completionMay 2007
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 Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Patricia V Højberg, MD, PHD, Principal investigator, University Hospital Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612950
- Sponsor's protocol ID
- KA 03005
- Other IDs
- KA 03005
- Status last verified
- Jan 2008
- First submitted
- 16 Jan 2008
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.
PubMed 19037628
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00612950
- Acronym / sponsor ID
- KA 03005
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Feb 2008 (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 incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Experimental | Drug: glucagon-like peptide-1, |
| GIP | Experimental | Drug: glucose dependent insulinotropic polypeptide |
| saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years
- Type 2 diabetes diagnosed after 30 years of age
- BMI > 25
Key exclusion criteria (6 listed)
- Severe complications to diabetes
- Abnormal liver and kidney function
- Haemoglobin below the lower limit
- Macroalbuminuria
- Systemic 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 |
|---|---|---|
| glucagon-like peptide-1,GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes. | Drug | GLP-1 |
| glucose dependent insulinotropic polypeptidecontinuous infusion of GIP (1½ pmol/kg/min) for 120 min. | Drug | GIP |
| Salinecontinuous infusion of Saline for 120 min | Drug | saline |
Primary outcome
2.phase insulin response measured as incremental area under the curve from 10-120 minutes
Time frame: 2 hours
1 secondary outcome
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment
Time frame: 2 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 12 Feb 2008.
- Derived from this study: PubMed 19037628Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.
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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.
Patricia V Højberg, MD, PHD principal investigator
University Hospital Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucagon-like peptide-1,, glucose dependent insulinotropic polypeptide and Saline in people with Type 2 Diabetes, 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 3 inclusion and 6 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 12 Feb 2008. 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.
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?
2.phase insulin response measured as incremental area under the curve from 10-120 minutes (time frame: 2 hours). 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 NCT00612950, 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 12 Feb 2008.