Poznan Prospective Study of Type 1 Diabetic Patients

Active, not recruiting

• Conditions: Insulin Treatment Overcorrection; Insulin Resistance; Macroangiopathy; Microangiopathy

• Registration Number: NCT01411033
• Lead Sponsor: Poznan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-01
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropathy	1 year
Retinopathy	1 year
Cardiovascular events	1 year	stroke, heart infarct, death
Diabetic chronic renal disease	1 year

Secondary Outcome Measures

Name	Time	Method
Intima media thickness	1 year
Metabolic management of diabetes	1 year	HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI
Quality of life	1 year