Type 1 Diabetes MellitusInLipoDiab1NCT02306005
Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.
An observational study of Type 1 Diabetes Mellitus, run by Poznan University of Medical Sciences at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2014to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- any other medical conditions, and any other additional drugs beyond insulin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
Poznan, 60-834
Aleksandra Uruska, PhD, 607620750 ext. +48, aleksandrauruska@gmail.com
Dorota Zozulinska-Ziolkiewicz, Prof, 618474579 ext. +48, kldiab@raszeja.poznan.pl
About this study
Official title: 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:
Read more
- The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
- Electrophoresis of plasma lipoproteins
- Electrophoresis of HDL
- 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
- 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),
- Metabolic management of diabetes,,
- Protein glycation end products
- 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.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes mellitus type 1, insulin therapy, lipoproteins, HDL
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipoproteins' metabolism
Evaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)
Measured: 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
Measured: 1 year
Secondary outcomes (5)
Changes in apolipoproteins
Evaluation of apolipoproteins: A-I, A-II, A-IV, C (II i III), D i E
Measured: 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
Measured: 1 year
Development of Retinopathy
Evaluation of retinopathy (ophthalmology assessment)
Measured: 1 year
Development of Neuropathy
Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)
Measured: 1 year
Development of Diabetic kidney disease
Evaluation of presence of diabetic kidney disease (albuminuria, GFR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Uruska, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306005
- Sponsor's protocol ID
- 856/14
- Acronym
- InLipoDiab1
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2014
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31379357Cieluch 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.
PubMed 29350676Uruska 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.
PubMed 40465557
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT02306005
- Acronym / sponsor ID
- InLipoDiab1 / 856/14
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes mellitus type 1, insulin therapy, lipoproteins, HDL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
- Electrophoresis of plasma lipoproteins
- Electrophoresis of HDL
- 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
- 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),
- Metabolic management of diabetes,,
- Protein glycation end products
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- any other medical conditions, and any other additional drugs beyond insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Factors influencing relationship between insulin treatment and lipoproteins
Time frame: 1 year
Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement
5 secondary outcomes
Changes in apolipoproteins
Time frame: Change from baseline in apolipoproteins' at 6 and 12 months
Presence of insulin resistance
Time frame: 1 year
Development of Retinopathy
Time frame: 1 year
Development of Neuropathy
Time frame: 1 year
Development of Diabetic kidney disease
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Results publication: PubMed 31379357Cieluch 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.
- Results publication: PubMed 29350676Cieluch 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.
- Derived from this study: PubMed 40465557Uruska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorota Zozulinska-Ziolkiewicz, Prof (618474579 ext. +48, kldiab@raszeja.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipoproteins' metabolism (time frame: Change from Baseline in lipoproteins' metabolism at 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306005, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.