Diabetes Mellitus Type 2NCT00612625
Near Normalisation of BG Improves the Potentiating Effect of GLP-1
A study testing glucagon-like peptide-1 and Saline in people with Diabetes Mellitus Type 2, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- glucagon-like peptide-1 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2004to Dec 2004
- 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 og 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: Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes
The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- glucagon-like peptide-1, 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-1Drug
continuous infusion of GLP-1 (1½ pmol/kg/min)
SalineDrug
continuous infusion of saline
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Experimental | A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min) Receives: Drug: glucagon-like peptide-1 |
| Saline | Experimental | A graded glucose infusion together with a continuous infusion of saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min
Measured: 180 minutes
Secondary outcomes (1)
The calculated ISR values was plotted against the ambient plasma glucose. The slopes of this linear relationships were calculated by cross-correlation analysis and is and estimation of beta-cell responsiveness (pmol/kg/min)/mmol/l
Measured: 180 minutes
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 startFeb 2004
- Primary completionJul 2004
- Study completionDec 2004
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 Diabetes Mellitus Type 2Studies 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
- 9 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
- NCT00612625
- Sponsor's protocol ID
- KF 01 - 198/03
- Other IDs
- KA 01 - 198/03
- 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, Zander M, Vilsboll T, Knop FK, Krarup T, Volund A, Holst JJ, Madsbad S. Near normalisation of blood glucose improves the potentiating effect of GLP-1 on glucose-induced insulin secretion in patients with type 2 diabetes. Diabetologia. 2008 Apr;51(4):632-40. doi: 10.1007/s00125-008-0943-x. Epub 2008 Feb 22.
PubMed 18292985
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
- Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00612625
- Acronym / sponsor ID
- KF 01 - 198/03
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Dec 2004 (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 ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Experimental | Drug: glucagon-like peptide-1A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min) |
| Saline | Experimental | Drug: SalineA graded glucose infusion together with a continuous infusion of 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 og 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-1continuous infusion of GLP-1 (1½ pmol/kg/min) | Drug | GLP-1 |
| Salinecontinuous infusion of saline | Drug | Saline |
Primary outcome
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min
Time frame: 180 minutes
1 secondary outcome
The calculated ISR values was plotted against the ambient plasma glucose. The slopes of this linear relationships were calculated by cross-correlation analysis and is and estimation of beta-cell responsiveness (pmol/kg/min)/mmol/l
Time frame: 180 minutes
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 18292985Hojberg PV, Zander M, Vilsboll T, Knop FK, Krarup T, Volund A, Holst JJ, Madsbad S. Near normalisation of blood glucose improves the potentiating effect of GLP-1 on glucose-induced insulin secretion in patients with type 2 diabetes. Diabetologia. 2008 Apr;51(4):632-40. doi: 10.1007/s00125-008-0943-x. Epub 2008 Feb 22.
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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 and Saline in people with Diabetes Mellitus Type 2, 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. 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?
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min (time frame: 180 minutes). 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 NCT00612625, 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.