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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Oxidative stress markers with the new slow insulin analogues
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- •Pregnancy or pregnancy planning.
- •Diabetes mellitus type
- •Hyperuricemia (uric acid ≥7 mg / dl at the time of inclusion or current treatment With allopurinol).
- •Absence of collaboration (informed consent).
研究组 & 干预措施
Tresiba & NovoRapid
Patients treated with Tresiba insulin and NovoRapid insulin
干预措施: Tresiba (Drug)
Tresiba & NovoRapid
Patients treated with Tresiba insulin and NovoRapid insulin
干预措施: NovoRapid (Drug)
Toujeo SoloStar & NovoRapid
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
干预措施: Toujeo SoloStar (Drug)
Toujeo SoloStar & NovoRapid
Patients treated with Toujeo SoloStar insulin and NovoRapid insulin
干预措施: NovoRapid (Drug)
Tresiba & Humalog Kwikpen
Patients treated with Tresiba insulin and Humalog kwikpen insulin
干预措施: Tresiba (Drug)
Tresiba & Humalog Kwikpen
Patients treated with Tresiba insulin and Humalog kwikpen insulin
干预措施: Humalog Kwikpen (Drug)
Toujeo SoloStar & Humalog Kwikpen
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
干预措施: Toujeo SoloStar (Drug)
Toujeo SoloStar & Humalog Kwikpen
Patients treated with Toujeo SoloStar insulin and Humalog kwikpen insulin
干预措施: Humalog Kwikpen (Drug)
Tresiba & Apidra
Patients treated with Tresiba insulin and Apidra insulin
干预措施: Tresiba (Drug)
Tresiba & Apidra
Patients treated with Tresiba insulin and Apidra insulin
干预措施: Apidra (Drug)
Toujeo SoloStar & Apidra
Patients treated with Toujeo SoloStar insulin and Apidra insulin
干预措施: Toujeo SoloStar (Drug)
Toujeo SoloStar & Apidra
Patients treated with Toujeo SoloStar insulin and Apidra insulin
干预措施: Apidra (Drug)
结局指标
主要结局
Oxidative stress markers with the new slow insulin analogues
时间窗: 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
次要结局
- Standard deviation(6 month)
- Number of mild hypoglycemia(6 month)
- Mean blood glucose(6 month)
- HbA1c(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)
研究者
Virginia Morillas
Maria Soledad Ruiz de Adana
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud