jRCTs051200080进行中（未招募）不适用
A multicenter, open-label, single-arm study with regard to the efficacy of 10-hydroxy-cis-12-octadecenoic acid on insulin sensitivity in patients with impaired glucose tolerance and mild diabetes mellitus
未提供0 个研究点目标入组 45 人开始时间: 2021年4月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 69age old under（—）
- 性别
- All
入选标准
- •Patients who are over 20 years and under 69 years at the time of consent acquisition (Regardless of gender)
- •Patients with BMI 25 kg/m 2 or more
- •Patients with impaired glucose tolerance and with diabetes mellitus 75 g OGTT diagnostic criteria for IGT or who do not use oral hypoglycemic drugs with HbA1c below 7.0%.
- •With regard to participation in this examination, patients who gained document consent by their own voluntary intention
排除标准
- •Patients with severe hepatic dysfunction
- •Patients with severe renal dysfunction
- •Patients with cancer
- •Patients who are treated with oral or intravenous steroids
- •Patients with the medical history of cardiovascular disease
- •Pregnant women or patients who may be pregnant or breast-feeding
- •Patients who have participated in other clinical trials related to weight loss or who have taken drugs or supplements that lead to weight loss in the last 3 months.
- •Patients who lose 5% of their weight within the last 3 months
- •Patients whom clinical researchers judged to be inappropriate
结局指标
主要结局
-
Changes in HOMA-IR from before HYA administration to 12 weeks after administration
次要结局
- Changes in the body weight and abdominal circumference(4 or 8, 12 weeks after administration)
- Changes in the body composition(12 weeks after administration)
- Changes in HOMA-IR(4 or 8 weeks after administration)
- Changes in the 75g OGTT(12 weeks after administration)
- Changes in the glucose metabolism marker(4 or 8, 12 weeks after administration)
- Changes in the pancreas glucagon and active GLP-1(12 weeks after administration)
- Changes in the adipokines(12 weeks after administration)
- Changes in the liver fibrosis marker(12 weeks after administration)
- Changes in the liver function(4 or 8, 12 weeks after administration)
- Changes in the lipid(12 weeks after administration)
- Changes in the free fatty acid(4 or 8, 12 weeks after administration)
- Changes in the short chain fatty acid concentration in stool(12 weeks after administration)
- Changes in the lipid metabolite in blood(12 weeks after administration)
- Changes in the lipid metabolite in stool(12 weeks after administration)
- Changes in the intestinal bacterial flora(12 weeks after administration)
- Whether or not adverse events after the start of HYA administration
- Changes in the blood pressure(4 or 8, 12 weeks after administration)
研究者
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