- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048268
Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.
From this, we will evaluate GIP's role as blood sugar stabilizer.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Copenhagen County
-
Hellerup, Copenhagen County, Denmark, 2900
- Department of Internal Medicine F' laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
- Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
- Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
- Normal hemoglobin
- Informed consent
Exclusion criteria:
- Unwillingness to participate or the wish to leave the present study
- HbA1c > 9 %
- Liver disease (ALAT or ASAT > 2 times normal value)
- Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
- Proliferative diabetic retinopathy (anamnetic)
- Atherosclerotic heart disease or heart failure (NYHA group III and IV)
- Anemia
- Treatment with medicine which cannot be paused for 12 hours
- Pregnancy and/or breast feeding
- Fasting plasma glucose > 15 mM on the day of the experiment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy volunteers
|
For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight. For the following 40 minutes the volunteers will receive 2 pmol/kg body weight
copy GIP infusion rates
|
EXPERIMENTAL: Patients with Type 1 diabetes mellitus
|
For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight. For the following 40 minutes the volunteers will receive 2 pmol/kg body weight
copy GIP infusion rates
|
EXPERIMENTAL: Patients with type 2 diabetes mellitus
|
For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight. For the following 40 minutes the volunteers will receive 2 pmol/kg body weight
copy GIP infusion rates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon
Time Frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
|
-10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference between the amount of infused glucose and the insulin responses
Time Frame: will be measured at each visit
|
will be measured at each visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mikkel Christensen, MD, Bispebjerg Hospital, Copenhagen
- Study Director: Filip K Knop, MD PhD, Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIP HYPO (MC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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