NCT03328845

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Toujeo SoloStar	Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
DRUG	Tresiba	Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
DRUG	Humalog Kwikpen	Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
DRUG	NovoRapid	Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl
DRUG	Apidra	Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels \< 150 mg/dl

Timeline

• Start date: 2017-01-20
• Primary completion: 2020-11-30
• Completion: 2021-11-20
• First posted: 2017-11-01
• Last updated: 2021-12-06

Locations

1 site across 1 country: Spain