Overview

This trial is active, not recruiting.

Conditions microangiopathy, macroangiopathy, insulin treatment overcorrection, insulin resistance
Sponsor Poznan University of Medical Sciences
Start date January 1994
Trial size 100 participants
Trial identifier NCT01411033, PPS1999

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Retinopathy
time frame: 1 year
Diabetic chronic renal disease
time frame: 1 year
Neuropathy
time frame: 1 year
Cardiovascular events
time frame: 1 year

Secondary Outcomes

Measure
Metabolic management of diabetes
time frame: 1 year
Quality of life
time frame: 1 year
Intima media thickness
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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)

Additional Information

Official title Poznan Prospective Study of Type 1 Diabetic Patients Treated With Intensive Insulin Therapy From the Onset of the Disease.
Principal investigator Dorota A Zozulinska-Ziolkiewicz, Prof
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Poznan University of Medical Sciences.