CTRI/2015/07/006015尚未招募不适用
A clinical study to determine the effect of a dietary fiber on plasma glucose levels in patients with Type II Diabetes Mellitus.
Mr Ajay Nilawar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年7月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the effect on the fasting and post prandial (PP) in patients with Type II Diabetes Mellitus.
研究概览
简要总结
This is a study in subjects with Type II diabetes mellitus.The main purpose of this study is to determine the effect of a dietary fiber in patients with type II Diabetes mellitus.Subjects who meet the eligibility criteria will be enrolled into the study. At the screening visit, retrospective data of subject’s blood sugars will be collected. In addition, fasting and PP sugars will be assessed at screening, week 2/ day 15, week 3/Day 22 and week 4/Day 29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Males and females 18 -65 years of age (both inclusive).
- •â€¢Diagnosed with type 2 diabetes mellitus •Fasting sugar greater than equal to 126 mg/dl and/or PP sugar greater than equal to 200 mg/dl •Stable dose of the anti-diabetic treatment in a period of 30 days prior to screening.
- •â€¢No plan to change the anti-diabetic treatment during subject’s participation in the study as judged by the Investigator at screening.
- •â€¢BMI less than or equal to 30 kg/m².
- •â€¢Must have adequate reports of the fasting and PP sugars of past 1 month from screening.
- •â€¢Must be willing to or likely to comply with all study requirements.
- •â€¢Must be able and willing to provide written informed consent.
- •â€¢Females of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
排除标准
- •â€¢Use of insulin.
- •â€¢Suffering from any chronic diseases or serious complications that may interfere with glucose metabolism which in opinion of the Investigator precludes trial participation.
- •â€¢Suffering from gastrointestinal diseases which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. subacute obstruction.
- •â€¢Current use of medication which in opinion of the Investigator may interfere with the digestion and nutrient absorption (for examples steroids, protease inhibitors or antipsychotics medications).
- •â€¢Current use of medication which in opinion of the Investigator is known to affect glucose tolerance (excluding oral contraceptives) and glucose estimation.
- •â€¢Known food allergy or intolerance, abuse of drugs or alcohol.
- •â€¢Known case of sensitivity to Gluten or Coeliac disease.
- •â€¢Pregnant or lactating females.
- •â€¢Currently participating or had participated in any other interventional study in last 1 month prior to screening •Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, inability to attend study visits required by the protocol).
结局指标
主要结局
To determine the effect on the fasting and post prandial (PP) in patients with Type II Diabetes Mellitus.
时间窗: Week 2, 3 and 4
次要结局
未报告次要终点
研究者
研究点 (1)
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