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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Odense University Hospital
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Lise Hald Nielsen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01821053
First received: March 26, 2013
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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
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 Odense University Hospital:

Primary Outcome Measures:
  • preeclampsia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    post-partum registration of preterm delivery

  • light for gestational age [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    post-partum registration of "light for gestational age"


Biospecimen Retention:   Samples With DNA

whole blood serum plasma urine


Estimated Enrollment: 130
Study Start Date: June 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
pregestational type 1 diabetes
It is an observational study. No intervention is made.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821053

Locations
Denmark
Gynelogical Obstetrical Department Recruiting
Skejby, Aarhus N, Denmark, 8200
Contact: Lise H. Nielsen, doctor    +4553347735    lihn@clin.au.dk   
Contact: Per Ovesen, doctor    +4561669728    Per.Ovesen@dadlnet.dk   
Principal Investigator: Lise H. Nielsen, Doctor         
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:
No publications provided

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
Study First Received: March 26, 2013
Last Updated: October 24, 2014
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on November 24, 2014