Type 2 DiabetesPhase 1NCT02673554
The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of GIP
A Phase 1 study testing GIP Bolus, GIP Clamp and Oral glucose tolerance test (OGTT) in people with Type 2 Diabetes, run by Diabeteszentrum Bad Lauterberg im Harz.
Trial summary
In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus bolus administration. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GIP Bolus, GIP Clamp and Oral glucose tolerance test (OGTT)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Dec 2008
- Phase
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Exclusion of impaired glucose tolerance or type 2 diabetes in metabolical healthy subjects
- current diagnosis of type 2 diabetes according to the guidelines of the German Diabetes Association (DDG) ( Kerner et al . 2001) in subjects of diabetes group
- fasting glucose ≤ 150 mg/dl
- Body-mass-index ≥ 20 kg/m²
- Written consent
- Type 1 diabetes
Show all 26Show fewer
- Impaired glucose tolerance or Type 2 diabetes in metabolical healthy subjects
- Ketone bodies urine diagnostics at least ++
- Acidosis
- Fasting blood glucose > 150 mg/dl
- Body-mass-index < 20 kg/m²
- No written consent
- Pregnancy or unsafe contraception in women before menopause
- Active malignancy
- Angina as current, unsolved clinical problem
- Inadequately treated or untreated arterial hypertension ( > 160 mmHg systolic and / or > 95 mmHg diastolic )
- Infection / fever > 37.5 ° C
- Treatment with glucocorticoids
- Insulin therapy within the last three months
- Anemia with a hemoglobin level < 12 g/dl
- Liver function limitations
- Renal impairment ( serum creatinine > 1.5 mg/dl )
- Alcohol or drug abuse
- Participation in clinical trials in the last 3 months
- Inability or unwillingness to comply with the requirements of the Protocol
- Known hypersensitivity to GIP
About this study
Official title: The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of Glucose-dependent Insulinotropic Polypeptide (GIP) in Patients With Type 2 Diabetes is Not Caused by Rapid Tachyphylaxis
In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus bolus administration. The design was a two-way crossover design comparing repeated bolus injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were age- gender- and weight-matched with type 2 diabetes, first degree relatives of such patients, and healthy subjects. Investigators performed a:
- Oral glucose challenge;
- hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg body weight at 30 and 120 min); and
- hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180 min).
To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives, and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90 min apart, and compared this to a continued intravenous infusion of GIP.
- Conditions
- Type 2 Diabetes
- Being tested
- GIP Bolus, GIP Clamp, Oral glucose tolerance test (OGTT), hyperglycemic clamp
- Keywords
- Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon-Like Peptide 1 (GLP-1), Incretin, Insulin secretion, Tachyphylaxis
- 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.
GIP BolusDrug
bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp
GIP ClampDrug
hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min
Oral glucose tolerance test (OGTT)Procedure or surgery
an oral glucose challenge (75 g)
hyperglycemic clampProcedure or surgery
a hyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l)
| Study group | Role | What they receive |
|---|---|---|
| Oral glucose tolerance test | Experimental | An oral glucose challenge (75 g) Receives: Procedure: Oral glucose tolerance test (OGTT) |
| GIP Bolus | Active comparator | Hyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l) with two repeated intravenous bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp Receives: Drug: GIP Bolus; Procedure: hyperglycemic clamp |
| GIP Infusion | Active comparator | Hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min Receives: Drug: GIP Clamp; Procedure: hyperglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretory response after GIP bolus or infusion.
Measured: 210 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startMay 2004
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabeteszentrum Bad Lauterberg im Harz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael A. Nauck, Diabeteszentrum Bad Lauterberg im Harz
- Investigators
- Michael A. Nauck, Prof., Principal investigator, Diabeteszentrum Bad Lauterberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673554
- Sponsor's protocol ID
- GIP and Tachyphylaxis
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of Glucose-dependent Insulinotropic Polypeptide (GIP) in Patients With Type 2 Diabetes is Not Caused by Rapid Tachyphylaxis
- ClinicalTrials.gov ID
- NCT02673554
- Acronym / sponsor ID
- GIP and Tachyphylaxis
- Conditions
- Type 2 Diabetes
- Keywords
- Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon-Like Peptide 1 (GLP-1), Incretin, Insulin secretion, Tachyphylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Diabeteszentrum Bad Lauterberg im HarzUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Dec 2008 (actual)
- First posted
- 4 Feb 2016 (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.
In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus bolus administration. The design was a two-way crossover design comparing repeated bolus injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were age- gender- and weight-matched with type 2 diabetes, first degree relatives of such patients, and healthy subjects. Investigators performed a:
- Oral glucose challenge;
- hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg body weight at 30 and 120 min); and
- hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180 min).
To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives, and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90 min apart, and compared this to a continued intravenous infusion of GIP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral glucose tolerance test | Experimental | Procedure: Oral glucose tolerance test (OGTT)An oral glucose challenge (75 g) |
| GIP Bolus | Active comparator | Drug: GIP Bolus, Procedure: hyperglycemic clampHyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l) with two repeated intravenous bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp |
| GIP Infusion | Active comparator | Drug: GIP Clamp, Procedure: hyperglycemic clampHyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- Exclusion of impaired glucose tolerance or type 2 diabetes in metabolical healthy subjects
- current diagnosis of type 2 diabetes according to the guidelines of the German Diabetes Association (DDG) ( Kerner et al . 2001) in subjects of diabetes group
- fasting glucose ≤ 150 mg/dl
- Body-mass-index ≥ 20 kg/m²
- Written consent
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 |
|---|---|---|
| GIP Bolusbolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp | Drug | GIP Bolus |
| GIP Clamphyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min | Drug | GIP Infusion |
| Oral glucose tolerance test (OGTT)an oral glucose challenge (75 g) | Procedure or surgery | Oral glucose tolerance test |
| hyperglycemic clampa hyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l) | Procedure or surgery | GIP Bolus, GIP Infusion |
Primary outcome
Insulin secretory response after GIP bolus or infusion.
Time frame: 210 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 4 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Michael A. Nauck, Prof. principal investigator
Diabeteszentrum Bad Lauterberg
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GIP Bolus, GIP Clamp and Oral glucose tolerance test (OGTT) in people with Type 2 Diabetes, run by Diabeteszentrum Bad Lauterberg im Harz.
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 0 inclusion and 26 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Insulin secretory response after GIP bolus or infusion. (time frame: 210 minutes). 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 4 Feb 2016.