Type 1 Diabetes Mellitus
Conditions
Keywords
Oxidation, Insulin analogues, Type 1 diabetes mellitus
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).
Interventions
DRUGToujeo SoloStar
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
DRUGTresiba
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
DRUGHumalog Kwikpen
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
DRUGNovoRapid
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
DRUGApidra
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress markers with the new slow insulin analogues | 6 month | To evaluate the impact on the circulating levels of oxidative stress markers of the different treatments using the new slow insulin analogues. 1a) Anti oxidation: Total antioxidant capacity (CAT), and 1b) Oxidation: 8-iso-prostaglandin F2 alpha (8-iso-PGF2α), thiobarbituric acid reactive substances (TBARS) and LDL-oxidized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean blood glucose | 6 month | Glycemic control: mean blood glucose (mg/dl) |
| Standard deviation | 6 month | Glycemic variability :standard deviation \[SD\] |
| Number of mild hypoglycemia | 6 month | Number of mild hypoglycaemia in two weeks |
| Number of severe hypoglycemia | 6 month | Number of severe hypoglycemia in the last 6 months |
| Number of hyperglycemia | 6 month | Number of hyperglycemia\> 250 mg / dl in two weeks |
| Episodes of ketosis | 6 month | Episodes of ketosis in the last 6 months |
| HbA1c | 6 month | Glycemic control: glycosylated hemoglobin |
| Quality of life questionnaire in diabetes (DQOL) | 6 month | 34 items on the quality of life of people with type 1 diabetes |
| Scale of adherence to treatment in patients with diabetes type 1 (DM1) | 6 month | 15 items related to adherence to patient treatment |
| Diabetes distress scale. DDS | 6 month | 17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005) |
| Fear of hypoglycemia: Questionnaire FH-15 | 6 month | 15 items related to the fear of hypoglycemia in patients with type 1 diabetes |
| Diabetes treatment satisfaction questionnaire (DTSQ). | 6 month | 8 items concerning the satisfaction of the treatment |
| Number os hospital admissions | 6 month | Number of hospital admissions for acute diabetes decompensation in the last 6 months. |
Countries
Spain
Outcome results
None listed