Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Neuropathy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Neuropathy
Time Frame: 1 year
Retinopathy
Time Frame: 1 year
Cardiovascular events
Time Frame: 1 year
stroke, heart infarct, death
Diabetic chronic renal disease
Time Frame: 1 year
Secondary Outcomes
- Intima media thickness(1 year)
- Metabolic management of diabetes(1 year)
- Quality of life(1 year)
Investigators
Aleksandra Uruska
Prof. Dorota Zozulinska -Ziolkiewicz
Poznan University of Medical Sciences