Glucose-dependent Insulinotropic Polypeptide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Healthy volunteers

Group Type EXPERIMENTAL

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

copy GIP infusion rates

Patients with Type 1 diabetes mellitus

Group Type EXPERIMENTAL

glucose-dependent insulinotropic polypeptide

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

copy GIP infusion rates

Patients with type 2 diabetes mellitus

Group Type EXPERIMENTAL

glucose-dependent insulinotropic polypeptide

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

copy GIP infusion rates

Interventions

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glucose-dependent insulinotropic polypeptide

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

Intervention Type DRUG

Placebo

copy GIP infusion rates

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes