Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Poznan Prospective Study of Type 1 Diabetic Patients (PoProStu)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Aleksandra Uruska, Poznan University of Medical Sciences Identifier:
First received: August 2, 2011
Last updated: September 10, 2014
Last verified: September 2014

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.

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:

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

Primary Outcome Measures:
  • Retinopathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Diabetic chronic renal disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Neuropathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    stroke, heart infarct, death

Secondary Outcome Measures:
  • Metabolic management of diabetes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intima media thickness [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA


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


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.


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
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 identifier: NCT01411033

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


Responsible Party: Aleksandra Uruska, Prof. Dorota Zozulinska -Ziolkiewicz, Poznan University of Medical Sciences Identifier: NCT01411033     History of Changes
Other Study ID Numbers: PPS1999
Study First Received: August 2, 2011
Last Updated: September 10, 2014
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on February 27, 2015