Evaluating insulin therapy effects on lipoproteins in type 1 diabetes
Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.
This study is testing how insulin therapy affects cholesterol levels in people who have just been diagnosed with type 1 diabetes over several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan) |
| Trial ID | NCT02306005 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how insulin therapy influences the lipid profile, particularly focusing on HDL metabolism, in patients newly diagnosed with type 1 diabetes. The study will involve at least 100 participants who will be monitored over a minimum of 5-10 years, with evaluations occurring at diagnosis, and at 3 weeks, 6 months, and 12 months after starting insulin treatment. Additionally, participants will undergo metabolic evaluations every three months at an outpatient clinic to track changes in plasma lipoprotein fractions and HDL subfractions.
Who should consider this trial
Good fit: Ideal candidates are individuals with newly diagnosed type 1 diabetes who are starting insulin therapy.
Not a fit: Patients with other medical conditions or those taking medications beyond insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing insulin therapy to improve lipid profiles in patients with type 1 diabetes.
How similar studies have performed: While similar studies have explored insulin's effects on lipid profiles, this specific focus on HDL metabolism in newly diagnosed type 1 diabetes is relatively novel.
Eligibility criteria
Show full 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
Where this trial is running
Poznan
- Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
Study contacts
- Study coordinator: Dorota Zozulinska-Ziolkiewicz, Prof
- Email: kldiab@raszeja.poznan.pl
- Phone: 618474579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.