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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Tresiba; Drug: Toujeo SoloStar; Drug: NovoRapid; Drug: Humalog Kwikpen; Drug: Apidra

• Registration Number: NCT03328845
• Lead Sponsor: 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).

Study Timeline

• Study Start: 2017-01-20
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-10-29
• Study First Posted: 2017-11-01
• Primary Completion: 2020-11-30
• Status Verified: 2021-11
• Study Completion: 2021-11-20
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tresiba & Humalog Kwikpen	Tresiba	Patients treated with Tresiba insulin and Humalog kwikpen insulin
Toujeo SoloStar & Humalog Kwikpen	Toujeo SoloStar	Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Toujeo SoloStar & Apidra	Toujeo SoloStar	Patients treated with Toujeo SoloStar insulin and Apidra insulin
Toujeo SoloStar & NovoRapid	Toujeo SoloStar	Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Tresiba & NovoRapid	NovoRapid	Patients treated with Tresiba insulin and NovoRapid insulin
Toujeo SoloStar & NovoRapid	NovoRapid	Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Tresiba & NovoRapid	Tresiba	Patients treated with Tresiba insulin and NovoRapid insulin
Tresiba & Apidra	Tresiba	Patients treated with Tresiba insulin and Apidra insulin
Tresiba & Humalog Kwikpen	Humalog Kwikpen	Patients treated with Tresiba insulin and Humalog kwikpen insulin
Tresiba & Apidra	Apidra	Patients treated with Tresiba insulin and Apidra insulin
Toujeo SoloStar & Humalog Kwikpen	Humalog Kwikpen	Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
Toujeo SoloStar & Apidra	Apidra	Patients treated with Toujeo SoloStar insulin and Apidra insulin

Primary Outcome Measures

Name	Time	Method
Oxidative stress markers with the new slow insulin analogues	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

Name	Time	Method
HbA1c	6 month	Glycemic control: glycosylated hemoglobin
Mean blood glucose	6 month	Glycemic control: mean blood glucose (mg/dl)
Standard deviation	6 month	Glycemic variability :standard deviation \[SD\]
Number of mild hypoglycemia	6 month	Number of mild hypoglycaemia in two weeks
Diabetes distress scale. DDS	6 month	17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col, 2005)
Number of severe hypoglycemia	6 month	Number of severe hypoglycemia in the last 6 months
Number of hyperglycemia	6 month	Number of hyperglycemia\> 250 mg / dl in two weeks
Episodes of ketosis	6 month	Episodes of ketosis in the last 6 months
Number os hospital admissions	6 month	Number of hospital admissions for acute diabetes decompensation in the last 6 months.
Quality of life questionnaire in diabetes (DQOL)	6 month	34 items on the quality of life of people with type 1 diabetes
Scale of adherence to treatment in patients with diabetes type 1 (DM1)	6 month	15 items related to adherence to patient treatment
Fear of hypoglycemia: Questionnaire FH-15	6 month	15 items related to the fear of hypoglycemia in patients with type 1 diabetes
Diabetes treatment satisfaction questionnaire (DTSQ).	6 month	8 items concerning the satisfaction of the treatment

Trial Locations

Locations (1)

Regional University Hospital of Málaga; 🇪🇸 Málaga, Spain