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Poznan Prospective Study of Type 1 Diabetic Patients (PoProStu)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01411033
First received: August 2, 2011
Last updated: March 7, 2013
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the development and progression of chronic complications (retinopathy, neuropathy, diabetic chronic renal disease, cardiovascular events) in patients with type 1 diabetes treated from the onset of the disease with recommended method of intensive insulin therapy. All patients attended a five-day structured training program during first hospitalization and re-education once year during the observation. After five years of observation and next - once a year chronic complications are assessed. The investigators would like to evaluate also the relationship of the management of the disease, knowledge about the treatment and diabetes, insulin resistance and inflammatory markers with development and progression of chronic complications.


Condition
Microangiopathy
Macroangiopathy
Insulin Treatment Overcorrection
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:
  • Retinopathy [ Time Frame: First evaluation after 5 years of observation and next - once a year ] [ Designated as safety issue: No ]
  • Diabetic chronic renal disease [ Time Frame: First evaluation after 5 years of observation and next - once a year ] [ Designated as safety issue: No ]
  • Neuropathy [ Time Frame: First evaluation after 5 years of observation and next - once a year ] [ Designated as safety issue: No ]
  • Cardiovascular events [ Time Frame: First evaluation after 5 years of observation and next - once a year ] [ Designated as safety issue: No ]
    stroke, heart infarct, death


Secondary Outcome Measures:
  • Metabolic management of diabetes [ Time Frame: once a year ] [ Designated as safety issue: No ]
    HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI

  • Quality of life [ Time Frame: once a year ] [ Designated as safety issue: No ]
  • Intima media thickness [ Time Frame: First evaluation after 5 years of observation and next - once a year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 100
Study Start Date: January 1994
Groups/Cohorts
Newly diagnosed diabetes mellitus type 1

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 Caucasian patients with newly diagnosed type 1 diabetes admitted to the Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences in years 1994-1999, treated from the onset of the disease with intensive insulintherapy.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411033

Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Principal Investigator: Dorota A Zozulinska-Ziolkiewicz, Prof Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
  More Information

Publications:

Responsible Party: Prof Dorota Zozulinska-Ziolkiewicz, Department of Internal Medicine and Diabetology
ClinicalTrials.gov Identifier: NCT01411033     History of Changes
Other Study ID Numbers: PPS1999
Study First Received: August 2, 2011
Last Updated: March 7, 2013
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Insulin Resistance
Vascular Diseases
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013