Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes. (InLipoDiab1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Aleksandra Uruska, PhD; Phone Number: +48 607620750; Email: aleksandrauruska@gmail.com
• Study Contact Backup: Name: Dorota Zozulinska-Ziolkiewicz, Prof; Phone Number: +48 618474579; Email: kldiab@raszeja.poznan.pl

Study Locations

• Poland
  • Poznan, Poland, 60-834
    • Recruiting
    • Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
    • Contact: Aleksandra Uruska, PhD; Phone Number: +48 607620750; Email: aleksandrauruska@gmail.com
    • Contact: Dorota Zozulinska-Ziolkiewicz, Prof; Phone Number: +48 618474579; Email: kldiab@raszeja.poznan.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A minimum of 100 people with newly diagnosed type 1 diabetes hospitalized in the Department of Internal Medicine and Diabetology Poznan University of Medical Sciences

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lipoproteins' metabolism	Evaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)	Change from Baseline in lipoproteins' metabolism at 6 and 12 months
Factors influencing relationship between insulin treatment and lipoproteins	Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in apolipoproteins	Evaluation of apolipoproteins: A-I, A-II, A-IV, C (II i III), D i E	Change from baseline in apolipoproteins' at 6 and 12 months
Presence of insulin resistance	Evaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate	1 year
Development of Retinopathy	Evaluation of retinopathy (ophthalmology assessment)	1 year
Development of Neuropathy	Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)	1 year
Development of Diabetic kidney disease	Evaluation of presence of diabetic kidney disease (albuminuria, GFR)	1 year

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: November 23, 2014
• First Submitted That Met QC Criteria: November 29, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: diabetes mellitus type 1, insulin therapy, lipoproteins, HDL
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: PoznanUMS