NCT01821053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2014

Enrollment Period

2.3 years

First QC Date

March 26, 2013

Last Update Submit

October 15, 2015

Conditions

PreeclampsiaType 1 Diabetes

Keywords

PreeclampsiaPregestational Type 1 diabetesdiabetes mellitusproteinuriaplasminogenplasminreninaldosteroneangiotensinepithelial sodium channelENaC

Outcome Measures

Primary Outcomes (1)

  • preeclampsia

    The development of preeclampsia, defined by hypertension ( \> 140/90 mmHg) and proteinuria ( \>0,3 g/24 hour).

    3 years

Secondary Outcomes (2)

  • preterm delivery

    3 years

  • light for gestational age

    3 years

Study Arms (1)

pregestational type 1 diabetes

It is an observational study. No intervention is made.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Possible comorbidity like systemic lupus erythematosus (SLE), hypertension and rheumatoid arthritis.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynelogical Obstetrical Department

Skejby, Aarhus N, 8200, Denmark

Location

Related Publications (2)

  • Isaksson GL, Nielsen LH, Palarasah Y, Jensen DM, Andersen LLT, Madsen K, Bistrup C, Jorgensen JS, Ovesen PG, Jensen BL. Urine excretion of C3dg and sC5b-9 coincide with proteinuria and development of preeclampsia in pregnant women with type-1 diabetes. J Hypertens. 2023 Feb 1;41(2):223-232. doi: 10.1097/HJH.0000000000003288.

    PMID: 36583350DERIVED

  • Nielsen LH, Jensen BL, Fuglsang J, Andersen LLT, Jensen DM, Jorgensen JS, Kitlen G, Ovesen P. Urine albumin is a superior predictor of preeclampsia compared to urine plasminogen in type I diabetes patients. J Am Soc Hypertens. 2018 Feb;12(2):97-107. doi: 10.1016/j.jash.2017.12.003. Epub 2017 Dec 13.

    PMID: 29305116DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood serum plasma urine

MeSH Terms

Conditions

Pre-EclampsiaDiabetes Mellitus, Type 1Diabetes MellitusProteinuria

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Boye L. Jensen, Professor

    cardiovascular and renal research department, Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor, Ph.D student

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 29, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 16, 2015

Record last verified: 2014-10

Locations

DK(1)