Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- change in plasma glucose AUC
研究概览
简要总结
The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).
详细描述
The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Type 2 diabetes mellitus
- •postmenopausal
- •HbA1c >6.49 and <14.1
排除标准
- •use of tobacco
- •substance abuse
- •impaired cognitive function
- •renal disease
- •abnormal liver function
- •gastrointestinal diseases
- •use of exogenous insulin
- •use of hormone replacement therapy currently or within past 6 months
- •pacemaker/defibrillator
结局指标
主要结局
change in plasma glucose AUC
时间窗: baseline and week 16
significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.
次要结局
- change in insulin sensitivity(baseline and every 4 weeks until week 16)
- change in glucose tolerance(baseline and every 4 weeks for 16 weeks)
- change in HbA1c(baseline and week 16)
- change in blood lipid profile(baseline and every 4 weeks for 16 weeks)
- change in serum adipocytokines(baseline and every 4 weeks for 16 weeks)
- change in hepatic enzymes(baseline and every 4 weeks for 16 weeks)
- change in body composition(baseline and every 4 weeks for 16 weeks)