Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.

Type 1 Diabetes Mellitus Clinical Trial

— InLipoDiab1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306005
• Other study ID #: PoznanUMS
• Status: Recruiting
• Start date: November 2014
• Est. completion date: January 2023

Study information

• Verified date: May 2020
• Source: Poznan University of Medical Sciences
• Contact: Dorota Zozulinska-Ziolkiewicz, Prof
• Phone: 618474579
• Email: kldiab[@]raszeja.poznan.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Poland	Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Cieluch A, Uruska A, Grzelka A, Zozulinska-Ziólkiewicz 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. P — View Citation

Cieluch A, Uruska A, Grzelka-Wozniak A, Niedzwiecki P, Flotynska J, Zozulinska-Ziólkiewicz 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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Factors influencing relationship between insulin treatment and lipoproteins	Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement	1 year
Secondary	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
Secondary	Presence of insulin resistance	Evaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate	1 year
Secondary	Development of Retinopathy	Evaluation of retinopathy (ophthalmology assessment)	1 year
Secondary	Development of Neuropathy	Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)	1 year
Secondary	Development of Diabetic kidney disease	Evaluation of presence of diabetic kidney disease (albuminuria, GFR)	1 year