Clinical trial NCT03328845: Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
Official title: Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. Clinical Trial of Low Level of Intervention. (Ineox Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Oxidation
Insulin analogues
Type 1 diabetes mellitus
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. - The circulating levels of oxidative stress markers: A) Anti oxidation: Total antioxidant capacity (CAT), B) Oxidation: 8-iso-prostaglandin F2 alpha (8-iso-PGF2α), acid reactive substances Thiobarbituric (TBARS) and LDL-oxidized.
2. - The relationship between glycemic control variables (HbA1c and mean glycemia) and variability (Standard deviation (SD), coefficient of variation (CV), and MAGE (mean amplitude of Glycemic excursions) and oxidative stress parameters analyzed.

Goal 2:

Study the activation of cellular pathways associated with processes and oxidation states, by means of a Array of expression of up to 50 genes encoding oxidative stress response genes as CPT1a (Carnitine Palmitoyl Transferase 1a, mitochondrial oxidizing b limiting enzyme), TAS (Fatty acyl synthetase), acetyl-coA carboxylase, Acadm (medium chain acyl dehydrogenase), Acadl (long chain acyl dehydrogenase), Acadvl (long chain acyl coA dehydrogenase), SOD1, Hmox1 and Glutamine-Cysteine ligase (Gclc).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Oxidative stress markers with the new slow insulin analogues
timeFrame: 6 month
Secondary outcomes:
measure: HbA1c
timeFrame: 6 month
measure: Mean blood glucose
timeFrame: 6 month
measure: Standard deviation
timeFrame: 6 month
measure: Number of mild hypoglycemia
timeFrame: 6 month
measure: Number of severe hypoglycemia
timeFrame: 6 month
measure: Number of hyperglycemia
timeFrame: 6 month
measure: Episodes of ketosis
timeFrame: 6 month
measure: Number os hospital admissions
timeFrame: 6 month
measure: Quality of life questionnaire in diabetes (DQOL)
timeFrame: 6 month
measure: Scale of adherence to treatment in patients with diabetes type 1 (DM1)
timeFrame: 6 month
measure: Diabetes distress scale. DDS
timeFrame: 6 month
measure: Fear of hypoglycemia: Questionnaire FH-15
timeFrame: 6 month
measure: Diabetes treatment satisfaction questionnaire (DTSQ).
timeFrame: 6 month
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Regional University Hospital of Málaga
Study officials:
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