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NCT Number: NCT01411033

Poznan Prospective Study of Type 1 Diabetic Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Microangiopathy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Treatment Overcorrection Macroangiopathy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Retinopathy

    Time frame: 1 year

  2. Diabetic chronic renal disease

    Time frame: 1 year

  3. Neuropathy

    Time frame: 1 year

  4. Cardiovascular events

    Time frame: 1 year

    stroke, heart infarct, death

Secondary outcomes

  1. Metabolic management of diabetes

    Time frame: 1 year

    HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI

  2. Quality of life

    Time frame: 1 year

  3. Intima media thickness

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease.

Acronym: PoProStu

Important dates

Study start
1994
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2011
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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