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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Regional University Hospital of Málaga
Málaga, Spain
Oxidative stress markers with the new slow insulin analogues
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
Time frame: 6 month
HbA1c
Glycemic control: glycosylated hemoglobin
Time frame: 6 month
Mean blood glucose
Glycemic control: mean blood glucose (mg/dl)
Time frame: 6 month
Standard deviation
Glycemic variability :standard deviation \[SD\]
Time frame: 6 month
Number of mild hypoglycemia
Number of mild hypoglycaemia in two weeks
Time frame: 6 month
Number of severe hypoglycemia
Number of severe hypoglycemia in the last 6 months
Time frame: 6 month
Number of hyperglycemia
Number of hyperglycemia\> 250 mg / dl in two weeks
Time frame: 6 month
Episodes of ketosis
Episodes of ketosis in the last 6 months
Time frame: 6 month
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Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Number os hospital admissions
Number of hospital admissions for acute diabetes decompensation in the last 6 months.
Time frame: 6 month
Quality of life questionnaire in diabetes (DQOL)
34 items on the quality of life of people with type 1 diabetes
Time frame: 6 month
Scale of adherence to treatment in patients with diabetes type 1 (DM1)
15 items related to adherence to patient treatment
Time frame: 6 month
Diabetes distress scale. DDS
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)
Time frame: 6 month
Fear of hypoglycemia: Questionnaire FH-15
15 items related to the fear of hypoglycemia in patients with type 1 diabetes
Time frame: 6 month
Diabetes treatment satisfaction questionnaire (DTSQ).
8 items concerning the satisfaction of the treatment
Time frame: 6 month