Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes. (InLipoDiab1)
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|ClinicalTrials.gov Identifier: NCT02306005|
Recruitment Status : Unknown
Verified November 2014 by Aleksandra Uruska, Poznan University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : December 3, 2014
Last Update Posted : December 3, 2014
The aim of the study is to evaluate the effect of insulin therapy in patients with newly diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, and analysis of the factors determining the effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100 people with newly diagnosed type 1 diabetes and lead prospective observation of this group (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6 months and after 12 months of insulin therapy. Further observations planned in the annual intervals. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic.
During each follow-up will be assessed parameters evaluating the metabolism of plasma lipoprotein fractions and subfractions of HDL:
- The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
- Electrophoresis of plasma lipoproteins
- Electrophoresis of HDL
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
- 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),
- Metabolic management of diabetes,,
- Protein glycation end products
- 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.
|Condition or disease|
|Type 1 Diabetes Mellitus|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2018|
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.
- Changes in lipoproteins' metabolism [ Time Frame: Change from Baseline in lipoproteins' metabolism at 6 and 12 months ]Evaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)
- Factors influencing relationship between insulin treatment and lipoproteins [ Time Frame: 1 year ]Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement
- Changes in apolipoproteins [ Time Frame: Change from baseline in apolipoproteins' at 6 and 12 months ]Evaluation of apolipoproteins: A-I, A-II, A-IV, C (II i III), D i E
- Presence of insulin resistance [ Time Frame: 1 year ]Evaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate
- Development of Retinopathy [ Time Frame: 1 year ]Evaluation of retinopathy (ophthalmology assessment)
- Development of Neuropathy [ Time Frame: 1 year ]Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)
- Development of Diabetic kidney disease [ Time Frame: 1 year ]Evaluation of presence of diabetic kidney disease (albuminuria, GFR)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306005
|Contact: Dorota Zozulinska-Ziolkiewicz, Prof||618474579 ext +firstname.lastname@example.org|
|Contact: Aleksandra Uruska, PhD||607620750 ext +email@example.com|
|Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences||Recruiting|
|Poznan, Poland, 60-834|
|Contact: Aleksandra Uruska, PhD 607620750 ext +48 firstname.lastname@example.org|
|Contact: Dorota Zozulinska-Ziolkiewicz, Prof 618474579 ext +48 email@example.com|