The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes

NCT ID: NCT00321321

Last Updated: 2015-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-04-30

Brief Summary

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The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Sulfonylurea

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus diagnosed according to WHO criteria
* Diet and/or metformin treatment
* HbA1c \> 7,0% for metformin treated patients
* HbA1c \> 7,5% for diet treated patients
* Age: 18 years or older
* 25 \> BMI \> 40 kg/m2
* Signed informed consent
* Sufficient birth control in case of child bearing capacity

Exclusion Criteria

* Proliferative retinopathy
* Diabetic nephropathy with s-creatinine \> 130 microM and/or macroalbuminuria
* Liver disease (ALAT \> 2 x normal value)
* CAD (NYHA group III or IV)
* Positive screening for islet-cell and/or GAD-65 autoantibodies
* Type 1 diabetes i first degree relatives
* Gastrointestinal surgery with intestinal resection
* Anemia
* Pregnancy and/or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Gentofte University Hospital

Principal Investigators

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Kasper Aaboe, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gentofte University Hospital

Locations

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Department of Internal Medicine, Gentofte University Hospital

Hellerup, Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA-05011

Identifier Type: -

Identifier Source: org_study_id

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