|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02306005 |
|
Date of registration:
|
23/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.
InLipoDiab1 |
|
Scientific title:
|
Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes. |
|
Date of first enrolment:
|
November 2014 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02306005 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Poland
| | | | | | | |
|
Contacts
|
|
Name:
|
Aleksandra Uruska, PhD |
|
Address:
|
|
|
Telephone:
|
607620750 |
|
Email:
|
aleksandrauruska@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Dorota Zozulinska-Ziolkiewicz, Prof |
|
Address:
|
|
|
Telephone:
|
618474579 |
|
Email:
|
kldiab@raszeja.poznan.pl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 1 Diabetes Mellitus
|
|
Primary Outcome(s)
|
|
Factors influencing relationship between insulin treatment and lipoproteins
[Time Frame: 1 year]
|
|
Changes in lipoproteins' metabolism
[Time Frame: Change from Baseline in lipoproteins' metabolism at 6 and 12 months]
|
|
Secondary Outcome(s)
|
|
Development of Retinopathy
[Time Frame: 1 year]
|
|
Presence of insulin resistance
[Time Frame: 1 year]
|
|
Development of Diabetic kidney disease
[Time Frame: 1 year]
|
|
Changes in apolipoproteins
[Time Frame: Change from baseline in apolipoproteins' at 6 and 12 months]
|
|
Development of Neuropathy
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
PoznanUMS
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|