Regional University Hospital of Málaga
Málaga, Spain
NCT Number: NCT03328845
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
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Málaga, Spain
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Other names: Glargina U300
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Other names: Degludec insulin
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other names: Lispro insulin
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other names: Aspart insulin
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other names: Glulisine insulin
Time frame: 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
Time frame: 6 month
Glycemic control: glycosylated hemoglobin
Time frame: 6 month
Glycemic control: mean blood glucose (mg/dl)
Time frame: 6 month
Glycemic variability :standard deviation [SD]
Time frame: 6 month
Number of mild hypoglycaemia in two weeks
Time frame: 6 month
Number of severe hypoglycemia in the last 6 months
Time frame: 6 month
Number of hyperglycemia> 250 mg / dl in two weeks
Time frame: 6 month
Episodes of ketosis in the last 6 months
Time frame: 6 month
Number of hospital admissions for acute diabetes decompensation in the last 6 months.
Time frame: 6 month
34 items on the quality of life of people with type 1 diabetes
Time frame: 6 month
15 items related to adherence to patient treatment
Time frame: 6 month
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)
Time frame: 6 month
15 items related to the fear of hypoglycemia in patients with type 1 diabetes
Time frame: 6 month
8 items concerning the satisfaction of the treatment
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Other
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)
Acronym: INEOX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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