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

This study has been completed.
Aarhus University Hospital
Information provided by (Responsible Party):
Lise Hald Nielsen, Odense University Hospital Identifier:
First received: March 26, 2013
Last updated: October 15, 2015
Last verified: October 2014
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.

Preeclampsia Type 1 Diabetes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Lise Hald Nielsen, Odense University Hospital:

Primary Outcome Measures:
  • 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:
  • preterm delivery [ Time Frame: 3 years ]
    post-partum registration of preterm delivery

  • 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

Enrollment: 85
Study Start Date: June 2013
Study Completion Date: October 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
pregestational type 1 diabetes
It is an observational study. No intervention is made.

  Show Detailed Description


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.

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
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Please refer to this study by its identifier: NCT01821053

Gynelogical Obstetrical Department
Skejby, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
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 Identifier: NCT01821053     History of Changes
Other Study ID Numbers: 1-10-72-1-13
Study First Received: March 26, 2013
Last Updated: October 15, 2015

Keywords provided by Lise Hald Nielsen, Odense University Hospital:
Pregestational Type 1 diabetes
diabetes mellitus
epithelial sodium channel

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 18, 2017