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Completed

NCT Number: NCT03328845

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional University Hospital of Málaga

Málaga, Spain

About this study

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:

  • - 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.
  • - 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Toujeo SoloStar

Drug

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

Tresiba

Drug

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

Humalog Kwikpen

Drug

Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl

Other names: Lispro insulin

NovoRapid

Drug

Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl

Other names: Aspart insulin

Apidra

Drug

Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl

Other names: Glulisine insulin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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)

Acronym: INEOX

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Nov 1, 2017
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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