Clinical trial NCT01048268: Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
Official title: Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus
Keywords: T1DM
T2DM
GIP
Glucose-dependent insulinotropic polypeptide
Incretin
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
Secondary outcomes:
measure: The difference between the amount of infused glucose and the insulin responses
timeFrame: will be measured at each visit
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal Medicine F' laboratory
state: Copenhagen County
Study officials:
affiliation: Bispebjerg Hospital, Copenhagen
name: Mikkel Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
name: Filip K Knop, MD PhD
role: STUDY_DIRECTOR
References:
citation: Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.