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The Incretin Effect in Patients With Gestational Diabetes Mellitus

M

Medical University of Lodz

Status

Completed

Conditions

Gestational Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT01307995
GDM-INK

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

GDM
Description:
Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT
NGT
Description:
Pregnant patients with normal glucose tolerance as observed in 75g OGTT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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