Status:
COMPLETED
Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study evaluates in a group of people with DM 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of insulin
Detailed Description
To evaluate by a randomized study in a group of people with DM 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of Insulin by analyzing: 1. \- T...
Eligibility Criteria
Inclusion
- Age between 18 years and 65 years (inclusive).
- DM1 of more than two years of evolution with habitual follow-up in the Diabetes Unit of the University Regional Hospital of Malaga.
- HbA1c ≤ 10%
- Intensive treatment with basal MDI - Bowl for more than 12 months prior to the start of study.
- Gives informed consent.
Exclusion
- Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- Pregnancy or pregnancy planning.
- Diabetes mellitus type 2.
- Hyperuricemia (uric acid ≥7 mg / dl at the time of inclusion or current treatment With allopurinol).
- Absence of collaboration (informed consent).
Key Trial Info
Start Date :
January 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03328845
Start Date
January 20 2017
End Date
November 20 2021
Last Update
December 6 2021
Active Locations (1)
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1
Regional University Hospital of Málaga
Málaga, Spain