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Clinical Trials/EUCTR2007-000634-39-DE
EUCTR2007-000634-39-DE
Active, not recruiting
Not Applicable

Postpartum Intervention in Women with Gestational Diabetes using Insulin - PINGUI

Forschergruppe Diabetes e. V. am Helmholtz Zentrum München0 sitesMarch 27, 2009
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Forschergruppe Diabetes e. V. am Helmholtz Zentrum München
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 27, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Forschergruppe Diabetes e. V. am Helmholtz Zentrum München

Eligibility Criteria

Inclusion Criteria

  • •1\.Female subjects who are at least 18 years of age, who are less than 7
  • •months post\-partum, and who had insulin treated GDM during their most
  • •recent pregnancy (see 8\)
  • •2\.Written informed consent to participate in the study
  • •3\.Ability to comply with all study requirements
  • •4\.Agree with the medication after finishing with breast feeding
  • •5\.Contraception after the last pregnancy for the next 2 years
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\.Pregnant or lactating female
  • •2\.GAD antibody or IA\-2 antibody positive
  • •3\.Diabetes, defined as any of the following (FPG \> 126mg/dL (7\.0 mmol/L) at visit 1 or 2\-hr post\-challenge plasma glucose (after a 75\-g OGTT) \> 200 mg/dL (11\.1 mmol/L) or diabetes diagnosed by a physician and confirmed by other clinical data, other than gestational diabetes
  • •4\.Use of insulin or any oral antidiabetic agents after pregnancy and prior to visit 1
  • •5\.concomitant use of drugs that affect carbohydrate metabolism
  • •6\.psychiatric disorders
  • •7\.history of vein thrombosis
  • •8\.bleeding disorders by clinical history
  • •9\.severe maternal or fetal complications during pregnancy
  • •10\.dietary only treatment during pregnancy

Outcomes

Primary Outcomes

Not specified

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