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

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)

Sponsors

Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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

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).

Overall Status Unknown status
Start Date January 2017
Completion Date December 2019
Primary Completion Date June 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Oxidative stress markers with the new slow insulin analogues 6 month
Secondary Outcome
Measure Time Frame
HbA1c 6 month
Mean blood glucose 6 month
Standard deviation 6 month
Number of mild hypoglycemia 6 month
Number of severe hypoglycemia 6 month
Number of hyperglycemia 6 month
Episodes of ketosis 6 month
Number os hospital admissions 6 month
Quality of life questionnaire in diabetes (DQOL) 6 month
Scale of adherence to treatment in patients with diabetes type 1 (DM1) 6 month
Diabetes distress scale. DDS 6 month
Fear of hypoglycemia: Questionnaire FH-15 6 month
Diabetes treatment satisfaction questionnaire (DTSQ). 6 month
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: Toujeo SoloStar

Other Name: Glargina U300

Intervention Type: Drug

Intervention Name: Tresiba

Other Name: Degludec insulin

Intervention Type: Drug

Intervention Name: Humalog Kwikpen

Other Name: Lispro insulin

Intervention Type: Drug

Intervention Name: NovoRapid

Other Name: Aspart insulin

Intervention Type: Drug

Intervention Name: Apidra

Other Name: Glulisine insulin

Eligibility

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).

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Contact

Last Name: Maria Soledad Ruiz de Adana, MD PhD

Phone: +34 629221089

Email: [email protected]

Location
Facility: Status: Contact: Regional University Hospital of Málaga Maria Soledad Ruiz de Adana, MD PhD +34 629221089 [email protected]
Location Countries

Spain

Verification Date

October 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Investigator Full Name: Virginia Morillas

Investigator Title: Maria Soledad Ruiz de Adana

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: Tresiba & NovoRapid

Type: Other

Description: Patients treated with Tresiba insulin and NovoRapid insulin

Label: Toujeo SoloStar & NovoRapid

Type: Other

Description: Patients treated with Toujeo SoloStar insulin and NovoRapid insulin

Label: Tresiba & Humalog Kwikpen

Type: Other

Description: Patients treated with Tresiba insulin and Humalog kwikpen insulin

Label: Toujeo SoloStar & Humalog Kwikpen

Type: Other

Description: Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin

Label: Tresiba & Apidra

Type: Other

Description: Patients treated with Tresiba insulin and Apidra insulin

Label: Toujeo SoloStar & Apidra

Type: Other

Description: Patients treated with Toujeo SoloStar insulin and Apidra insulin

Acronym INEOX
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov