Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.

NCT02306005 | Recruiting

• 1 other identifier: 856/14
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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. 1.The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
2. 2.Electrophoresis of plasma lipoproteins
3. 3.Electrophoresis of HDL
4. 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
5. 5.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),
6. 6.Metabolic management of diabetes,,
7. 7.Protein glycation end products
8. 8.The concentration of plasma adipokines.

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes mellitus type 1, insulin therapy, lipoproteins, HDL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes in apolipoproteins

  Change from baseline in apolipoproteins' at 6 and 12 months

• Presence of insulin resistance

  1 year

• Development of Retinopathy

  1 year

• Development of Neuropathy

  1 year

• Development of Diabetic kidney disease

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences

Poznan, 60-834, Poland

RECRUITING

Related Publications (3)

• 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.

  PMID: 31379357 RESULT

• 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.

  PMID: 29350676 RESULT

• 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.

  PMID: 40465557 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dorota Zozulinska-Ziolkiewicz, Prof

CONTACT

618474579; kldiab@raszeja.poznan.pl

Aleksandra Uruska, PhD

CONTACT

607620750; aleksandrauruska@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: December 3, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

PL (1)