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Urine-plasminogen as a Predictor for Development Of Preeclampsia in Pregnant Women With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01821053
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A tonic active epithelial Na+ channel (ENaC) in pre-eclampsia (PE) escaped normal hormonal control may offer an attractive explanatory model for the pathophysiology of established PE. The channel is activated by plasmin. Microalbuminuria predicts the development of pre-eclampsia in pregnant patients with pregestational diabetes type 1. The investigators hypothesize that urine-plasmin excreted in the kidneys, when proteinuria occurs, could be the cause. The investigators want to test the correlation between measurable plasmin/plasminogen in the urine early in pregnancy and the development of preeclampsia in pregnant patients with type 1 diabetes.

Condition or disease
Preeclampsia Type 1 Diabetes

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urine-plasminogen as a Predictor for Development Of Preeclampsia in Pregnant Women With Type 1 Diabetes Mellitus
Study Start Date : June 2013
Primary Completion Date : September 2015
Study Completion Date : October 2015


Groups and Cohorts

Group/Cohort
pregestational type 1 diabetes
It is an observational study. No intervention is made.


Outcome Measures

Primary Outcome Measures :
  1. preeclampsia [ Time Frame: 3 years ]
    The development of preeclampsia, defined by hypertension ( > 140/90 mmHg) and proteinuria ( >0,3 g/24 hour).


Secondary Outcome Measures :
  1. preterm delivery [ Time Frame: 3 years ]
    post-partum registration of preterm delivery

  2. light for gestational age [ Time Frame: 3 years ]
    post-partum registration of "light for gestational age"


Biospecimen Retention:   Samples With DNA
whole blood serum plasma urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women with pregestational type 1 diabtes are included when they show up for their first outpatient pregnancy visit around the 9th weeks gestation.
Criteria

Inclusion Criteria:

  • singleton gravida,
  • over 18 years,
  • Pregestational type 1 diabetes. Gestation week 8-14.

Exclusion Criteria:

  1. Possible comorbidity like systemic lupus erythematosus (SLE), hypertension and rheumatoid arthritis.
  2. Organic or systematic diseases with clinical relevance ( ex. Malignity)

However it has to be mentioned that quite some patients have thyroid diseases with no impact on the kidneys nor hypertension. It is therefore possible to include these patients.

Thyroid diseases are NOT a reason for exclusion.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821053


Locations
Denmark
Gynelogical Obstetrical Department
Skejby, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Investigators
Study Director: Boye L. Jensen, Professor cardiovascular and renal research department, Odense University Hospital
More Information

Additional Information:
Responsible Party: Lise Hald Nielsen, doctor, Ph.D student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01821053     History of Changes
Other Study ID Numbers: 1-10-72-1-13
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2014

Keywords provided by Lise Hald Nielsen, Odense University Hospital:
Pregestational Type 1 diabetes
diabetes mellitus
Preeclampsia
proteinuria
plasminogen
plasmin
renin
aldosterone
angiotensin
epithelial sodium channel
ENaC

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Pre-Eclampsia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action