Effect of the Supplementation With β-carotene to Type 2 Diabetic Patients and Healthy Controls on the Iron Status and Antioxidant Capacity of Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Changes in oxidative status
研究概览
简要总结
Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
详细描述
Type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. The objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.
A total of 117 volunteers participated in the study. Type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. Blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, HDL, LDL, oxidized LDL, copper, zinc, TBARS, FRAP, nitrites, GPx, SOD, folates, retinol and β-carotene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a diagnose of Type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics Patients in regular control (once a month) in the Hospital
排除标准
- •Hospitalized patient
- •Diabetic patient with diabetes related acute complications (ketoacidosis, hyperosmolar coma)in the 3 months previous to the study.
- •Individuals with infections that required antibiotics in the 3 weeks previous to the study.
- •Individuals with antibodies anti-insulin, autoimmune diseases or in treatment with immunosuppressive drugs.
- •Individuals with viral infections such as hepatitis B, hematological, renal or hepatic diseases.
- •Pregnancy
结局指标
主要结局
Changes in oxidative status
时间窗: Time 0, 45 days and 75 days after supplementation
次要结局
- Hemoglobin and hematocrit(Time 0, 45 days and 75 days after supplementation)
- Ferritin(Time 0, 45 days and 75 days after supplementation)
- Iron metabolism markers(Time 0, 45 days and 75 days after supplementation)
- Blood Chemistry(Time 0, 45 days and 75 days after supplementation)
- Glycosylated Hemoglobin(Time 0, 45 days and 75 days after supplementation)
- Oxidized LDL(Time 0, 45 days and 75 days after supplementation)
- Thiobarbituric Acid Reactive substances (TBARS)(Time 0, 45 days and 75 days after supplementation)
- Ferric Reducing ability of Plasma (FRAP).(Time 0, 45 days and 75 days after supplementation)
- Activities of the enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx).(Time 0, 45 days and 75 days after supplementation)
- Serum zinc and copper.(Time 0, 45 days and 75 days after supplementation)
- β-carotene.(Time 0, 45 days and 75 days after supplementation)
- Serum retinol(Time 0, 45 days and 75 days after supplementation)
- Serum nitrites(Time 0, 45 days and 75 days after supplementation)
- Serum and erythrocyte folates.(Time 0, 45 days and 75 days after supplementation)
研究者
Maria Nieves Garcia-Casal
Director of Pathophysiology Laboratory
Instituto Venezolano de Investigaciones Cientificas