Type-1 Diabetes MellitusNCT00603031
Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus
A study testing glucagon like peptide -1, NaCl and glucose dependent insulinotropic polypeptide in people with Type-1 Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type-1 Diabetes Mellitus
- What is being tested?
- glucagon like peptide -1, NaCl and glucose dependent insulinotropic polypeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Jun 2008
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- Type-1 diabetes diagnosed between 5-40 years of age
- Normal weight(BMI 18-27),
- Insulin treatment from time of diagnosis.
Who cannot join
- Severe complications to diabetes
- Abnormal liver or 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: Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus
study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.
- Conditions
- Type-1 Diabetes Mellitus
- Being tested
- glucagon like peptide -1, NaCl, glucose dependent insulinotropic polypeptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucagon like peptide -1Other
continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
NaClOther
infusion with NaCl for 120 minutes as placebo-arm
glucose dependent insulinotropic polypeptideOther
continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Experimental | time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). Receives: Other: glucagon like peptide -1 |
| NaCl | Placebo comparator | time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). Receives: Other: NaCl |
| GIP | Experimental | time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). Receives: Other: glucose dependent insulinotropic polypeptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose
Measured: 2 hours
Secondary outcomes (1)
maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)
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 posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-1 Diabetes MellitusStudies 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
- Urd Kielgast, MD, Principal investigator, unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603031
- Sponsor's protocol ID
- H-D-2007-0076
- Other IDs
- 2008-000305-11, 2008
- Status last verified
- Aug 2009
- First submitted
- 15 Jan 2008
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00603031
- Acronym / sponsor ID
- H-D-2007-0076
- Conditions
- Type-1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 28 Jan 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.
study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.
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 | Other: glucagon like peptide -1time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). |
| NaCl | Placebo comparator | Other: NaCltime -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). |
| GIP | Experimental | Other: glucose dependent insulinotropic polypeptidetime -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Type-1 diabetes diagnosed between 5-40 years of age
- Normal weight(BMI 18-27),
- Insulin treatment from time of diagnosis.
Key exclusion criteria (6 listed)
- Severe complications to diabetes
- Abnormal liver or 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 1,2 pmol pr. kg pr minute at 120 minutes | Other | GLP-1 |
| NaClinfusion with NaCl for 120 minutes as placebo-arm | Other | NaCl |
| glucose dependent insulinotropic polypeptidecontinuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes. | Other | GIP |
Primary outcome
phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose
Time frame: 2 hours
1 secondary outcome
maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)
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 21 Jan 2011.
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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.
Urd Kielgast, MD principal investigator
unafilliated
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, NaCl and glucose dependent insulinotropic polypeptide in people with Type-1 Diabetes Mellitus, 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 4 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 21 Jan 2011. 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?
phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose (time frame: 2 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 21 Jan 2011.