Poznan Prospective Study of Type 1 Diabetic Patients

NCT01411033 | Active Not Recruiting

• 1 other identifier: 05/08/2003
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microangiopathy; Macroangiopathy; Insulin Treatment Overcorrection; Insulin Resistance

Outcome Measures

Primary Outcomes (4)

• Retinopathy

  1 year

• Diabetic chronic renal disease

  1 year

• Neuropathy

  1 year

• Cardiovascular events

  stroke, heart infarct, death

  1 year

Secondary Outcomes (3)

• Metabolic management of diabetes

  1 year

• Quality of life

  1 year

• Intima media thickness

  1 year

Study Arms (1)

Newly diagnosed diabetes mellitus type 1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 Caucasian patients with newly diagnosed type 1 diabetes admitted to the Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences in years 1994-1999, treated from the onset of the disease with intensive insulintherapy.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Related Publications (15)

• 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 Biochem. 2012 Dec;45(18):1620-3. doi: 10.1016/j.clinbiochem.2012.08.019. Epub 2012 Aug 29.

  PMID: 22960236 RESULT

• Wegner M, Piorunska-Stolzmann M, Araszkiewicz A, Zozulinska-Ziolkiewicz 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.

  PMID: 22157813 RESULT

• 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;90(2):e23-4. doi: 10.1016/j.diabres.2010.05.010. Epub 2010 Jun 11. No abstract available.

  PMID: 20541277 RESULT

• Wegner M, Araszkiewicz A, Zozulinska-Ziolkiewicz 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 acetylhydrolase in the serum of patients with type 1 diabetes. Magnes Res. 2010 Jun;23(2):97-104. doi: 10.1684/mrh.2010.0207. Epub 2010 May 27.

  PMID: 20507838 RESULT

• 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 Diabetes. 2010 Aug;118(8):478-84. doi: 10.1055/s-0030-1249635. Epub 2010 Apr 6.

  PMID: 20373280 RESULT

• Wegner M, Araszkiewicz A, Piorunska-Mikolajczak A, Zozulinska-Ziolkiewicz 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 therapy. Clin Biochem. 2009 Nov;42(16-17):1621-7. doi: 10.1016/j.clinbiochem.2009.07.023. Epub 2009 Aug 3.

  PMID: 19651120 RESULT

• 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 Res Clin Pract. 2008 Jul;81(1):61-7. doi: 10.1016/j.diabres.2008.02.009. Epub 2008 Apr 2.

  PMID: 18378034 RESULT

• 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.

  PMID: 15754632 RESULT

• 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.2014.06.014. Epub 2014 Jun 20.

  PMID: 24956263 RESULT

• 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.

  PMID: 24423616 RESULT

• Grzelka A, Naskret D, Araszkiewicz A, Uruska A, Wegner M, Zozulinska-Ziolkiewicz 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):1343-1349. doi: 10.17219/acem/65072.

  PMID: 29442454 RESULT

• 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: 10.1016/j.diabet.2016.12.007. Epub 2017 Jan 27. No abstract available.

  PMID: 28139435 RESULT

• Grzelka A, Araszkiewicz A, Uruska A, Zozulinska-Ziolkiewicz 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.

  PMID: 25923090 RESULT

• 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 type 1 diabetic patients. Results from Poznan Prospective Study. Microvasc Res. 2015 Mar;98:62-7. doi: 10.1016/j.mvr.2015.01.002. Epub 2015 Jan 10.

  PMID: 25582078 RESULT

• 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 Prospective Study). Adv Med Sci. 2014 Sep;59(2):240-4. doi: 10.1016/j.advms.2013.12.005. Epub 2014 Jun 9.

  PMID: 25090481 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dorota A Zozulinska-Ziolkiewicz, Prof

  Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dorota Zozulinska -Ziolkiewicz

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 5, 2011
• Study Start: January 1, 1994
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 5, 2024

Record last verified: 2024-12