A Randomized, Double-blind, Placebo-controlled Study on the Influence of Pinitol on Carbohydrate, Lipid and Inflammatory Parameters, Endothelial Function and Oxidative Stress in Diabetic, Impaired and Normal Fasting Glucose Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration
研究概览
简要总结
The purpose of this study was to assess whether pinitol improves hidrocarbonated metabolism parameters, and evaluate its effect on oxidative stress and endothelial function in diabetic, impaired and normal fasting glucose subjects.
This was a 3-month randomised, controlled-placebo, parallel trial with a three-arm design. Patients were divided into three groups: diabetic (n=40), impaired fasting glucose (n=40) or normal fasting glucose subjects (n=40), receiving 4 g/day of pinitol/placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range of 18-70 years.
- •Normal fasting glucose subjects were diagnosed as fasting glucose <100 mg/dl and HbA1c <5.7%.
- •Impaired fasting glucose subjects were diagnosed as fasting glucose between 100 and 125 mg/dl and/or HbA1c between 5.7 and 6.4%.
- •Type 2 Diabetes subjects were diagnosed as basal plasma glucose ≥ 126 mg/dl, at least twice, or glucose levels 2 hours after 75 g oral glucose overload ≥ 200 mg/dl (American Diabetes Association)
排除标准
- •Morbid obesity
- •Type 1 diabetes
- •Heart, liver, thyroid or kidney untreated disease
- •Neoplasic disease
- •Hypertriglyceridemia (Triglycerides >400 mg/dl),
- •Use of drugs that can influence the inflammatory state or insulin sensitivity (NSAIDs, corticosteroids, antiTNFα) and
- •Uncontrolled type 2 diabetes (HbA1c ≥ 8%) or with insulin or intestinal disaccharidase inhibitors (acarbose, miglyol,...) treatment.
研究组 & 干预措施
Diabetic subjects
Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.
干预措施: Pinitol (Dietary Supplement)
Impaired fasting glucose subjects
Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.
干预措施: Pinitol (Dietary Supplement)
Normal fasting glucose subjects
Before pinitol/placebo administration a four weeks run-in period of a healthy diet will be follow for all subjects. After this adaptation period, each subject will be randomized (1:1) into one of two groups: one that received the pinitol-enriched beverage (4 g/day) (n=20), and the other a placebo beverage (n=20) for 12 weeks.
干预措施: Pinitol (Dietary Supplement)
结局指标
主要结局
To assess hidrocarbonated metabolism parameters before and after pinitol/placebo administration
时间窗: 3 months
Blood samples were collected in vacutainer serum separator tubes, after 12- hour overnight fasting, to analyze glucose and insulin concentration at baseline (after a four weeks run-in period of a healthy diet), 6 and 12 weeks after pinitol/placebo administration. Glucose concentrations were measured by means of enzymatic assay in an autoanalyzer. Insulin concentrations were determined by enzyme-linked immunosorbent assay. In a representative group of patients of all groups at time 0 and 10 weeks, a 24 hours glucose levels control were assessed (by means of a continuous glucose monitoring system) for 3 days. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) index (fasting insulin (μIU/ml) x fasting glucose (mg/dl) /405). Glycosylated hemoglobin (HbA1c) was measured at baseline and 12 weeks in diabetic and impaired fasting glucose subjects.
次要结局
- To evaluate endothelial function before and after pinitol/placebo administration(3 months)
- To evaluate oxidative stress on mitochondrial function before and after pinitol/placebo administration(3 months)
- To evaluate lipid parameters before and after pinitol/placebo administration(3 months)
- To evaluate inflammatory parameters before and after pinitol/placebo administration(3 months)
研究者
Antonio Hernández Mijares
PhD, MD
University of Valencia