GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

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

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-11-30

Brief Summary

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Investigation of GIP effects at fasting and hypoglycemia

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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hyperglycemia

Group Type EXPERIMENTAL

Glucose-dependent Insulinotropic polypeptide

Intervention Type OTHER

infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min

saline

Intervention Type OTHER

fasting glycemia

Group Type EXPERIMENTAL

Glucose-dependent Insulinotropic polypeptide

Intervention Type OTHER

infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min

saline

Intervention Type OTHER

hypoglycemia

Group Type EXPERIMENTAL

Glucose-dependent Insulinotropic polypeptide

Intervention Type OTHER

infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min

saline

Intervention Type OTHER

Interventions

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Glucose-dependent Insulinotropic polypeptide

infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min

Intervention Type OTHER

saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria

* HbA1c \>9 %
* Liver disease (ALAT/ASAT \>2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \>130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III og IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* Fasting plasma glucose \>15 mM on screening day.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No