The Incretin Effect in Patients With Gestational Diabetes Mellitus

NCT ID: NCT01307995

Last Updated: 2011-03-03

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-05-31

Brief Summary

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The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Groups

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GDM

Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT

No interventions assigned to this group

NGT

Pregnant patients with normal glucose tolerance as observed in 75g OGTT

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age above 18 years old
* GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)

Exclusion Criteria

* Previous diagnosis of DM
* Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
* Affected biochemical liver parameters (ALAT \> 2 times normal upper range)
* Affected biochemical kidney parameters (se-creatinine \> 130 µM)
* Treatment with medicine interacting with insulin secretion (e.g. steroids)
* Treatment with medicine that can not be paused for 16 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Diabetology and Metabolic Diseases Departament

Principal Investigators

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Katarzyna Cypryk, MD, PhD, Asoc. Prof.

Role: STUDY_DIRECTOR

Medical University Lodz

Tina Vilsbøll, MD, DMSc

Role: STUDY_DIRECTOR

University of Copenhagen

Marcin Kosiński, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Lodz

Locations

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Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital

Lodz, , Poland

Site Status

Countries

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Poland

Other Identifiers

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GDM-INK

Identifier Type: -

Identifier Source: org_study_id

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