Poznan Prospective Study of Type 1 Diabetic Patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01411033

Acronym

PoProStu

Enrollment

100

Registered

2011-08-05

Start date

1994-01-31

Completion date

2028-12-31

Last updated

2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Insulin Treatment Overcorrection, Macroangiopathy, Microangiopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Retinopathy	1 year	—
Diabetic chronic renal disease	1 year	—
Neuropathy	1 year	—
Cardiovascular events	1 year	stroke, heart infarct, death

Secondary

Measure	Time frame	Description
Quality of life	1 year	—
Intima media thickness	1 year	—
Metabolic management of diabetes	1 year	HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI

Outcome results