Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
NCT ID: NCT03328845
Last Updated: 2021-12-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-01-20
Study Completion Date
2021-11-20
Brief Summary
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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
Detailed Description
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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).
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).
Conditions
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Type 1 Diabetes Mellitus
Keywords
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Oxidation
Insulin analogues
Type 1 diabetes mellitus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Tresiba & NovoRapid
Patients treated with Tresiba insulin and NovoRapid insulin
Group Type
OTHER
Tresiba
Intervention Type
DRUG
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
NovoRapid
Intervention Type
DRUG
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Toujeo SoloStar & NovoRapid
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Group Type
OTHER
Toujeo SoloStar
Intervention Type
DRUG
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
NovoRapid
Intervention Type
DRUG
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Tresiba & Humalog Kwikpen
Patients treated with Tresiba insulin and Humalog kwikpen insulin
Group Type
OTHER
Tresiba
Intervention Type
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
Intervention Type
DRUG
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Toujeo SoloStar & Humalog Kwikpen
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Group Type
OTHER
Toujeo SoloStar
Intervention Type
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
Intervention Type
DRUG
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Tresiba & Apidra
Patients treated with Tresiba insulin and Apidra insulin
Group Type
OTHER
Tresiba
Intervention Type
DRUG
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Apidra
Intervention Type
DRUG
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Toujeo SoloStar & Apidra
Patients treated with Toujeo SoloStar insulin and Apidra insulin
Group Type
OTHER
Toujeo SoloStar
Intervention Type
DRUG
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Apidra
Intervention Type
DRUG
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Interventions
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Toujeo SoloStar
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Intervention Type
DRUG
Tresiba
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Intervention Type
DRUG
Humalog Kwikpen
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Intervention Type
DRUG
NovoRapid
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Intervention Type
DRUG
Apidra
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
Intervention Type
DRUG
Other Intervention Names
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Glargina U300
Degludec insulin
Lispro insulin
Aspart insulin
Glulisine insulin
Eligibility Criteria
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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.
* 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).
* 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).
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Sponsor Role
lead
Responsible Party
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Virginia Morillas
Maria Soledad Ruiz de Adana
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Regional University Hospital of Málaga
Málaga, , Spain
Site Status
Countries
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Spain
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FIM-EOX-2016-01
Identifier Type: -
Identifier Source: org_study_id