Insulin Therapy and Lipoproteins' Profile in 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
| Condition(s) | Type 1 Diabetes Mellitus |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 o |
| Who can participate | 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 |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Lead sponsor | Poznan University of Medical Sciences |
| Locations | Poznan, Poland |
| Start date | 2014-11 |
| NCT ID | NCT02306005 |
| Official listing | https://clinicaltrials.gov/study/NCT02306005 |