Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.
NCT ID: NCT02306005
Last Updated: 2024-12-05
Study Results
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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RECRUITING
300 participants
OBSERVATIONAL
2014-11-30
2028-01-31
Brief Summary
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During each follow-up will be assessed parameters evaluating the metabolism of plasma lipoprotein fractions and subfractions of HDL:
1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
2. Electrophoresis of plasma lipoproteins
3. Electrophoresis of HDL
4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma lipoprotein lipase Moreover, evaluation of factors which may potentially modify the relation between insulin therapy and lipoproteins will be assessed
1. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip ratio, the estimated rate of glucose distribution, VAI index, body fat, blood pressure),
2. Metabolic management of diabetes,,
3. Protein glycation end products
4. The concentration of plasma adipokines.
Expected impact of the research project on the development of science, civilization and society The obtained results allow to assess the impact of exogenous insulin on quantitative and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1 diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it seem to be very important in the treatment of patients with type 1 diabetes, where insulin is the treatment of choice and dosage adjustment appears to be extremely important. Remains unknown whether the changes in the lipoprotein profile result from the beginning of insulin therapy or other factors influence it. Selecting a group of patients with less favorable lipoprotein profile may allow better metabolic control, and thus will affect the quality and length of life of our patients. These studies will assess the impact of our therapeutic actions on the diagnosis of the disease on long-term consequences, such as the development of chronic complications.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Type 1 diabetic patients
Newly diagnosed diabetes type 1 admitted to the Department of Internal Medicine and Diabetology. Measurement of lipid profile and lipoproteins before and after administration of insulin. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Written consent to participate in the study.
* There are no other medical conditions, and with no other additional drugs beyond insulin
Exclusion Criteria
18 Years
35 Years
ALL
No
Sponsors
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Poznan University of Medical Sciences
OTHER
Responsible Party
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Aleksandra Uruska
PhD, MD
Locations
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Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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Aleksandra Uruska, PhD
Role: primary
Dorota Zozulinska-Ziolkiewicz, Prof
Role: backup
References
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Cieluch A, Uruska A, Grzelka-Wozniak A, Niedzwiecki P, Flotynska J, Zozulinska-Ziolkiewicz D. Changes in high-density lipoprotein cholesterol (HDL-C) level and the ratio of triglycerides to HDL-C during the first year of type 1 diabetes. Pol Arch Intern Med. 2019 Sep 30;129(9):598-604. doi: 10.20452/pamw.14920. Epub 2019 Aug 5.
Cieluch A, Uruska A, Grzelka A, Zozulinska-Ziolkiewicz D. An increase in high-density lipoprotein cholesterol concentration after initiation of insulin treatment is dose-dependent in newly diagnosed type 1 diabetes. The results of the InLipoDiab1 study. Pol Arch Intern Med. 2018 Jan 31;128(1):69-71. doi: 10.20452/pamw.4183. Epub 2018 Jan 19. No abstract available.
Uruska A, Mietkiewska-Dolecka M, Grzelka-Wozniak A, Flotynska J, Saldanha S, Rohatgi A, Zozulinska-Ziolkiewicz D. Clinical remission in newly diagnosed type 1 diabetes mellitus and HDL function on cholesterol efflux capacity: prospective InLipoDiab1 study. Endocr Connect. 2025 Jun 17;14(6):e240704. doi: 10.1530/EC-24-0704. Print 2025 Jun 1.
Other Identifiers
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856/14
Identifier Type: -
Identifier Source: org_study_id