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Poznan Prospective Study of Type 1 Diabetic Patients

NCT ID: NCT01411033

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-01-31

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Microangiopathy Macroangiopathy Insulin Treatment Overcorrection Insulin Resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Newly diagnosed diabetes mellitus type 1

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Uruska

Prof. Dorota Zozulinska -Ziolkiewicz

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorota A Zozulinska-Ziolkiewicz, Prof

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type RESULT
PMID: 22960236 (View on PubMed)

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.

Reference Type RESULT
PMID: 22157813 (View on PubMed)

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.

Reference Type RESULT
PMID: 20541277 (View on PubMed)

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.

Reference Type RESULT
PMID: 20507838 (View on PubMed)

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.

Reference Type RESULT
PMID: 20373280 (View on PubMed)

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.

Reference Type RESULT
PMID: 19651120 (View on PubMed)

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.

Reference Type RESULT
PMID: 18378034 (View on PubMed)

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.

Reference Type RESULT
PMID: 15754632 (View on PubMed)

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.

Reference Type RESULT
PMID: 24956263 (View on PubMed)

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.

Reference Type RESULT
PMID: 24423616 (View on PubMed)

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.

Reference Type RESULT
PMID: 29442454 (View on PubMed)

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.

Reference Type RESULT
PMID: 28139435 (View on PubMed)

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.

Reference Type RESULT
PMID: 25923090 (View on PubMed)

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.

Reference Type RESULT
PMID: 25582078 (View on PubMed)

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.

Reference Type RESULT
PMID: 25090481 (View on PubMed)

Other Identifiers

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05/08/2003

Identifier Type: -

Identifier Source: org_study_id