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Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study) (INEOX)

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ClinicalTrials.gov Identifier: NCT03328845
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Toujeo SoloStar Drug: Tresiba Drug: Humalog Kwikpen Drug: NovoRapid Drug: Apidra Phase 4

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Tresiba & NovoRapid
Patients treated with Tresiba insulin and NovoRapid insulin
Drug: Tresiba
Other Name: Degludec insulin
Drug: NovoRapid
Other Name: Aspart insulin
Toujeo SoloStar & NovoRapid
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Drug: Toujeo SoloStar
Other Name: Glargina U300
Drug: NovoRapid
Other Name: Aspart insulin
Tresiba & Humalog Kwikpen
Patients treated with Tresiba insulin and Humalog kwikpen insulin
Drug: Tresiba
Other Name: Degludec insulin
Drug: Humalog Kwikpen
Other Name: Lispro insulin
Toujeo SoloStar & Humalog Kwikpen
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Drug: Toujeo SoloStar
Other Name: Glargina U300
Drug: Humalog Kwikpen
Other Name: Lispro insulin
Tresiba & Apidra
Patients treated with Tresiba insulin and Apidra insulin
Drug: Tresiba
Other Name: Degludec insulin
Drug: Apidra
Other Name: Glulisine insulin
Toujeo SoloStar & Apidra
Patients treated with Toujeo SoloStar insulin and Apidra insulin
Drug: Toujeo SoloStar
Other Name: Glargina U300
Drug: Apidra
Other Name: Glulisine insulin


Outcome Measures

Primary Outcome Measures :
  1. Oxidative stress markers with the new slow insulin analogues [ 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


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 6 month ]
    Glycemic control: glycosylated hemoglobin

  2. Mean blood glucose [ Time Frame: 6 month ]
    Glycemic control: mean blood glucose (mg/dl)

  3. Standard deviation [ Time Frame: 6 month ]
    Glycemic variability :standard deviation [SD]

  4. Number of mild hypoglycemia [ Time Frame: 6 month ]
    Number of mild hypoglycaemia in two weeks

  5. Number of severe hypoglycemia [ Time Frame: 6 month ]
    Number of severe hypoglycemia in the last 6 months

  6. Number of hyperglycemia [ Time Frame: 6 month ]
    Number of hyperglycemia> 250 mg / dl in two weeks

  7. Episodes of ketosis [ Time Frame: 6 month ]
    Episodes of ketosis in the last 6 months

  8. Number os hospital admissions [ Time Frame: 6 month ]
    Number of hospital admissions for acute diabetes decompensation in the last 6 months.

  9. Quality of life questionnaire in diabetes (DQOL) [ Time Frame: 6 month ]
    34 items on the quality of life of people with type 1 diabetes

  10. Scale of adherence to treatment in patients with diabetes type 1 (DM1) [ Time Frame: 6 month ]
    15 items related to adherence to patient treatment

  11. Diabetes distress scale. DDS [ Time Frame: 6 month ]
    17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)

  12. Fear of hypoglycemia: Questionnaire FH-15 [ Time Frame: 6 month ]
    15 items related to the fear of hypoglycemia in patients with type 1 diabetes

  13. Diabetes treatment satisfaction questionnaire (DTSQ). [ Time Frame: 6 month ]
    8 items concerning the satisfaction of the treatment


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328845


Contacts
Contact: Maria Soledad Ruiz de Adana, MD PhD +34 629221089 solruizdeadana@gmail.com

Locations
Spain
Regional University Hospital of Málaga Recruiting
Málaga, Spain
Contact: Maria Soledad Ruiz de Adana, MD PhD    +34 629221089    solruizdeadana@gmail.com   
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
More Information

Publications:

Responsible Party: Virginia Morillas, Maria Soledad Ruiz de Adana, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03328845     History of Changes
Other Study ID Numbers: FIM-EOX-2016-01
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Virginia Morillas, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Oxidation
Insulin analogues
Type 1 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin glulisine
Insulin
Insulin Lispro
Insulin Aspart
Insulin, Long-Acting
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs