Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

University Hospital, Gentofte, Copenhagen30 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

glucose-dependent insulinotropic polypeptideDRUG

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

PlaceboDRUG

copy GIP infusion rates

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Internal Medicine F' laboratory

Hellerup, Copenhagen County, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

The difference between the amount of infused glucose and the insulin responses

Time frame: will be measured at each visit

Data from ClinicalTrials.gov

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