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

November 23, 2021 updated by: Virginia Morillas, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain
        • Regional University Hospital of Malaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tresiba & NovoRapid
Patients treated with Tresiba insulin and NovoRapid insulin
Drug: Tresiba
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Other Names:
  • Degludec insulin
Drug: NovoRapid
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other Names:
  • Aspart insulin
Other: Toujeo SoloStar & NovoRapid
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
Drug: NovoRapid
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other Names:
  • Aspart insulin
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.
Other Names:
  • Glargina U300
Other: Tresiba & Humalog Kwikpen
Patients treated with Tresiba insulin and Humalog kwikpen insulin
Drug: Tresiba
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Other Names:
  • Degludec insulin
Drug: Humalog Kwikpen
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other Names:
  • Lispro insulin
Other: Toujeo SoloStar & Humalog Kwikpen
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
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.
Other Names:
  • Glargina U300
Drug: Humalog Kwikpen
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other Names:
  • Lispro insulin
Other: Tresiba & Apidra
Patients treated with Tresiba insulin and Apidra insulin
Drug: Tresiba
Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.
Other Names:
  • Degludec insulin
Drug: Apidra
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other Names:
  • Glulisine insulin
Other: Toujeo SoloStar & Apidra
Patients treated with Toujeo SoloStar insulin and Apidra insulin
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.
Other Names:
  • Glargina U300
Drug: Apidra
Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other Names:
  • Glulisine insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 month
Glycemic control: glycosylated hemoglobin
6 month
Mean blood glucose
Time Frame: 6 month
Glycemic control: mean blood glucose (mg/dl)
6 month
Standard deviation
Time Frame: 6 month
Glycemic variability :standard deviation [SD]
6 month
Number of mild hypoglycemia
Time Frame: 6 month
Number of mild hypoglycaemia in two weeks
6 month
Number of severe hypoglycemia
Time Frame: 6 month
Number of severe hypoglycemia in the last 6 months
6 month
Number of hyperglycemia
Time Frame: 6 month
Number of hyperglycemia> 250 mg / dl in two weeks
6 month
Episodes of ketosis
Time Frame: 6 month
Episodes of ketosis in the last 6 months
6 month
Number os hospital admissions
Time Frame: 6 month
Number of hospital admissions for acute diabetes decompensation in the last 6 months.
6 month
Quality of life questionnaire in diabetes (DQOL)
Time Frame: 6 month
34 items on the quality of life of people with type 1 diabetes
6 month
Scale of adherence to treatment in patients with diabetes type 1 (DM1)
Time Frame: 6 month
15 items related to adherence to patient treatment
6 month
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)
6 month
Fear of hypoglycemia: Questionnaire FH-15
Time Frame: 6 month
15 items related to the fear of hypoglycemia in patients with type 1 diabetes
6 month
Diabetes treatment satisfaction questionnaire (DTSQ).
Time Frame: 6 month
8 items concerning the satisfaction of the treatment
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 20, 2021

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIM-EOX-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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