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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
Sponsor:
Collaborators:
Department of Clinical Biochemistry and Laboratory Medicine
Department of Internal Medicine and Diabetology
Information provided by (Responsible Party):
Aleksandra Uruska, Poznan University of Medical Sciences

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.


Condition or disease
Type 1 Diabetes Mellitus

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.



Primary Outcome Measures :
  1. 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)

  2. Factors influencing relationship between insulin treatment and lipoproteins [ Time Frame: 1 year ]
    Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement


Secondary Outcome Measures :
  1. 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

  2. Presence of insulin resistance [ Time Frame: 1 year ]
    Evaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate

  3. Development of Retinopathy [ Time Frame: 1 year ]
    Evaluation of retinopathy (ophthalmology assessment)

  4. Development of Neuropathy [ Time Frame: 1 year ]
    Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)

  5. Development of Diabetic kidney disease [ Time Frame: 1 year ]
    Evaluation of presence of diabetic kidney disease (albuminuria, GFR)


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Dorota Zozulinska-Ziolkiewicz, Prof 618474579 ext +48 kldiab@raszeja.poznan.pl
Contact: Aleksandra Uruska, PhD 607620750 ext +48 aleksandrauruska@gmail.com

Locations
Poland
Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences Recruiting
Poznan, Poland, 60-834
Contact: Aleksandra Uruska, PhD    607620750 ext +48    aleksandrauruska@gmail.com   
Contact: Dorota Zozulinska-Ziolkiewicz, Prof    618474579 ext +48    kldiab@raszeja.poznan.pl   
Sponsors and Collaborators
Poznan University of Medical Sciences
Department of Clinical Biochemistry and Laboratory Medicine
Department of Internal Medicine and Diabetology

Responsible Party: Aleksandra Uruska, PhD, MD, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02306005     History of Changes
Other Study ID Numbers: PoznanUMS
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: November 2014

Keywords provided by Aleksandra Uruska, Poznan University of Medical Sciences:
diabetes mellitus type 1, insulin therapy, lipoproteins, HDL

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs