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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2013 |
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Main ID: |
NCT01411033 |
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Date of registration:
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02/08/2011 |
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Primary sponsor: |
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Public title:
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Poznan Prospective Study of Type 1 Diabetic Patients
PoProStu |
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Scientific title:
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Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease. |
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Date of first enrolment:
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January 1994 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01411033 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Contacts
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Name:
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Dorota A Zozulinska-Ziolkiewicz, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly diagnosed type 1 diabetes mellitus with features of complete insulin deficiency
(serum C-peptide level <0.05 ng/ml, acetonuria, blood gases disturbances such as:
pH <7.30, BE< -6 mmol/l, HCO3 <18 mmol/l)
- Age < 35 years old
- Educational course in intensive insulin therapy started at the onset of the disease
after treatment of ketoacidosis
- Written consent
Exclusion Criteria:
- Uncertain type of diabetes mellitus
- Kidney failure (serum creatinine level > 1.1 mg/dl)
- Liver dysfunction (AspAt > 31 U/l, AlAt > 34 U/l)
- Acute inflammatory process
- Other concomitant diseases (i.e. neoplasm)
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Insulin Treatment Overcorrection
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Macroangiopathy
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Microangiopathy
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Primary Outcome(s)
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Cardiovascular events
[Time Frame: First evaluation after 5 years of observation and next - once a year]
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Diabetic chronic renal disease
[Time Frame: First evaluation after 5 years of observation and next - once a year]
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Neuropathy
[Time Frame: First evaluation after 5 years of observation and next - once a year]
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Retinopathy
[Time Frame: First evaluation after 5 years of observation and next - once a year]
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Secondary Outcome(s)
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Intima media thickness
[Time Frame: First evaluation after 5 years of observation and next - once a year]
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Metabolic management of diabetes
[Time Frame: once a year]
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Quality of life
[Time Frame: once a year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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