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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tresiba & NovoRapid | Other | Patients treated with Tresiba insulin and NovoRapid insulin |
|
| Toujeo SoloStar & NovoRapid | Other | Patients treated with Toujeo SoloStar insulin and NovoRapid insulin |
|
| Tresiba & Humalog Kwikpen | Other | Patients treated with Tresiba insulin and Humalog kwikpen insulin |
|
| Toujeo SoloStar & Humalog Kwikpen | Other | Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin |
|
| Tresiba & Apidra | Other | Patients treated with Tresiba insulin and Apidra insulin |
|
| Toujeo SoloStar & Apidra | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toujeo SoloStar | Drug | Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Glycemic control: glycosylated hemoglobin | 6 month |
| Mean blood glucose | Glycemic control: mean blood glucose (mg/dl) | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional University Hospital of Málaga | Málaga | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11232040 | Background | Aljada A, Ghanim H, Saadeh R, Dandona P. Insulin inhibits NFkappaB and MCP-1 expression in human aortic endothelial cells. J Clin Endocrinol Metab. 2001 Jan;86(1):450-3. doi: 10.1210/jcem.86.1.7278. | |
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Patients treated with Toujeo SoloStar insulin and Apidra insulin |
|
|
| Tresiba | Drug | Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl. |
|
|
| Humalog Kwikpen | Drug | Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl |
|
|
| NovoRapid | Drug | Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl |
|
|
| Apidra | Drug | Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl |
|
|
| Standard deviation | Glycemic variability :standard deviation [SD] | 6 month |
| Number of mild hypoglycemia | Number of mild hypoglycaemia in two weeks | 6 month |
| Number of severe hypoglycemia | Number of severe hypoglycemia in the last 6 months | 6 month |
| Number of hyperglycemia | Number of hyperglycemia> 250 mg / dl in two weeks | 6 month |
| Episodes of ketosis | Episodes of ketosis in the last 6 months | 6 month |
| Number os hospital admissions | Number of hospital admissions for acute diabetes decompensation in the last 6 months. | 6 month |
| Quality of life questionnaire in diabetes (DQOL) | 34 items on the quality of life of people with type 1 diabetes | 6 month |
| Scale of adherence to treatment in patients with diabetes type 1 (DM1) | 15 items related to adherence to patient treatment | 6 month |
| Diabetes distress scale. DDS | 17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005) | 6 month |
| Fear of hypoglycemia: Questionnaire FH-15 | 15 items related to the fear of hypoglycemia in patients with type 1 diabetes | 6 month |
| Diabetes treatment satisfaction questionnaire (DTSQ). | 8 items concerning the satisfaction of the treatment | 6 month |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided