Poznan Prospective Study of Type 1 Diabetic Patients

Insulin Resistance Clinical Trial

— PoProStu  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01411033
• Other study ID #: PPS1999
• Status: Active, not recruiting
• Start date: January 1994
• Est. completion date: December 2023

Study information

• Verified date: May 2020
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Treatment Overcorrection
• Macroangiopathy
• Microangiopathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

References & Publications (15)

Araszkiewicz A, Naskret D, Zozulinska-Ziolkiewicz D, Pilacinski S, Uruska A, Grzelka A, Wegner M, Wierusz-Wysocka B. Skin autofluorescence is associated with carotid intima-media thickness, diabetic microangiopathy, and long-lasting metabolic control in t — View Citation

Araszkiewicz A, Uruska A, Zozulinska-Ziolkiewicz D, Pilacinski S, Wierusz-Wysocka B. Factors related to insulin resistance in type 1 diabetic patients treated with intensive insulin therapy from the onset of the disease. Diabetes Res Clin Pract. 2010 Nov; — View Citation

Araszkiewicz A, Zozulinska D, Trepinska M, Wierusz-Wysocka B. [Is intensive functional insulin therapy the method of choice in newly diagnosed type-1 diabetes mellitus?]. Pol Merkur Lekarski. 2004 Nov;17(101):463-6. Polish. — View Citation

Araszkiewicz A, Zozulinska-Ziolkiewicz D, Pilacinski S, Naskret D, Uruska A, Wierusz-Wysocka B. Baseline diabetic knowledge after 5-day teaching program is an independent predictor of subclinical macroangiopathy in patients with type 1 diabetes (Poznan Pr — View Citation

Araszkiewicz A, Zozulinska-Ziolkiewicz D, Trepinska M, Wierusz-Wysocka B. Knowledge after five-day teaching program in intensive insulin therapy performed at the onset of type 1 diabetes influence the development of late diabetic complications. Diabetes R — View Citation

Grzelka A, Araszkiewicz A, Uruska A, Zozulinska-Ziólkiewicz D. Prevalence of anti-thyroid peroxidase in adults with type 1 diabetes participating in Poznan Prospective Study. Adv Clin Exp Med. 2015 Jan-Feb;24(1):79-84. doi: 10.17219/acem/38149. — View Citation

Grzelka A, Naskret D, Araszkiewicz A, Uruska A, Wegner M, Zozulinska-Ziólkiewicz D. Higher concentrations of osteoprotegerin in type 1 diabetic patients are related to retinopathy: Results from the Poznan Prospective Study. Adv Clin Exp Med. 2017 Dec;26(9 — View Citation

Uruska A, Araszkiewicz A, Uruski P, Zozulinska-Ziolkiewicz D. Higher risk of microvascular complications in smokers with type 1 diabetes despite intensive insulin therapy. Microvasc Res. 2014 Mar;92:79-84. doi: 10.1016/j.mvr.2014.01.002. Epub 2014 Jan 12. — View Citation

Uruska A, Araszkiewicz A, Zozulinska-Ziolkiewicz D, Uruski P, Wierusz-Wysocka B. Insulin resistance is associated with microangiopathy in type 1 diabetic patients treated with intensive insulin therapy from the onset of disease. Exp Clin Endocrinol Diabet — View Citation

Uruska A, Araszkiewicz A, Zozulinska-Ziolkiewicz D, Wegner M, Grzelka A, Wierusz-Wysocka B. Does serum cystatin C level reflect insulin resistance in patients with type 1 diabetes? Clin Biochem. 2014 Sep;47(13-14):1235-8. doi: 10.1016/j.clinbiochem.2014.0 — View Citation

Uruska A, Niedzwiecki P, Araszkiewicz A, Zozulinska-Ziolkiewicz D. Brain-derived neurotrophic factor and insulin resistance during hyperinsulinaemic-euglycaemic clamp in type 1 diabetes patients in the PoProStu. Diabetes Metab. 2017 Oct;43(5):472-474. doi — View Citation

Wegner M, Araszkiewicz A, Piorunska-Mikolajczak A, Zozulinska-Ziólkiewicz D, Wierusz-Wysocka B, Piorunska-Stolzmann M. The evaluation of IL-12 concentration, PAF-AH, and PLA(2) activity in patients with type 1 diabetes treated with intensive insulin thera — View Citation

Wegner M, Araszkiewicz A, Zozulinska-Ziólkiewicz D, Wierusz-Wysocka B, Piorunska-Mikolajczak A, Piorunska-Stolzmann M. The relationship between concentrations of magnesium and oxidized low density lipoprotein and the activity of platelet activating factor — View Citation

Wegner M, Piorunska-Stolzmann M, Araszkiewicz A, Zozulinska-Ziolkiewicz D, Naskret D, Uruska A, Wierusz-Wysocka B. Does oxidized LDL contribute to atherosclerotic plaque formation and microvascular complications in patients with type 1 diabetes? Clin Bioc — View Citation

Wegner M, Piorunska-Stolzmann M, Araszkiewicz A, Zozulinska-Ziólkiewicz D, Wierusz-Wysocka B. Evaluation of paraoxonase 1 arylesterase activity and lipid peroxide levels in patients with type 1 diabetes. Pol Arch Med Wewn. 2011 Dec;121(12):448-54. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinopathy		1 year
Primary	Diabetic chronic renal disease		1 year
Primary	Neuropathy		1 year
Primary	Cardiovascular events	stroke, heart infarct, death	1 year
Secondary	Metabolic management of diabetes	HbA1c, hypoglycaemic episodes, lipid profile, blood pressure, BMI	1 year
Secondary	Quality of life		1 year
Secondary	Intima media thickness		1 year