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Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.

Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02306005
Acronym
InLipoDiab1
Enrollment
300
Registered
2014-12-03
Start date
2014-11-30
Completion date
2028-01-31
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes mellitus type 1, insulin therapy, lipoproteins, HDL

Brief summary

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: 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.

Interventions

None listed

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* New onset type 1 diabetes and treatment with insulin. * Written consent to participate in the study. * There are no other medical conditions, and with no other additional drugs beyond insulin

Exclusion criteria

* any other medical conditions, and any other additional drugs beyond insulin

Design outcomes

Primary

MeasureTime frameDescription
Changes in lipoproteins' metabolismChange from Baseline in lipoproteins' metabolism at 6 and 12 monthsEvaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)
Factors influencing relationship between insulin treatment and lipoproteins1 yearMetabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement

Secondary

MeasureTime frameDescription
Development of Retinopathy1 yearEvaluation of retinopathy (ophthalmology assessment)
Changes in apolipoproteinsChange from baseline in apolipoproteins' at 6 and 12 monthsEvaluation of apolipoproteins: A-I, A-II, A-IV, C (II i III), D i E
Development of Diabetic kidney disease1 yearEvaluation of presence of diabetic kidney disease (albuminuria, GFR)
Development of Neuropathy1 yearEvaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)
Presence of insulin resistance1 yearEvaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate

Countries

Poland

Contacts

Primary ContactDorota Zozulinska-Ziolkiewicz, Prof
kldiab@raszeja.poznan.pl618474579
Backup ContactAleksandra Uruska, PhD
aleksandrauruska@gmail.com607620750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 7, 2026