CTRI/2018/02/012035已完成不适用
A Randomized, double-blind, parallel, placebo-controlled, interventional Study to Evaluate the Effect of Test/placebo biscuits in Regulating Blood Glucose and Safety in Pre-diabetic Subjects
ITC Life Sciences and Technology Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年5月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effects assessed in terms of maintenance and/or mean change in blood glucose (FBG, PPBG) from baseline to end of treatment i.e. 12 weeks, between the two test biscuit groups and compare to placebo group
研究概览
简要总结
This study was a randomized, double blind, parallel group trial for evaluating the safety and efficacy of test/placebo biscuits in pre-diabetic subjects. Total 150 subjects were enrolled from single center (India) to get at least 129 evaluable subjects.
To access outcome maintenance and /or mean change in fasting blood glucose from baseline to end of treatment i.e week 12 and safety of biscuits in pre-diabetic subjects maintenance and /or mean change in parameters like HbA1c, HDL, VLDL, TG, BP, Fructosamine level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females greater than or equal to 18 and less than or equal to 65 years of age
- •Body mass index of greater than or equal to 18.5 and less than or equal to 30 kg per m2
- •Pre-diabetic subjects with fasting blood glucose between 100 and 125 mg/dL (called impaired fasting glucose or IFG), IGT (greater than or equal to 140 and less than 200), and HbA1c levels greater than or equal to 5.7% and less than or equal to 6.4%
- •Subjects willing to comply with diet control
- •Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within three months prior to enrollment
- •If on anti-hypertensive therapy, the dosage must be constant for at least 2 months prior to the screening visit, based on medical history.
- •Females of child-bearing potential and males should be willing to use adequate methods of contraception.
- •Must be willing to give written informed consent and comply with the study procedures.
排除标准
- •Type 1 or type 2 diabetes mellitus
- •Subject with lipid abnormalities or thyroid disorders
- •Pregnant or lactating women
- •Subjects requiring a fibre free diet
- •Subject requiring enteral tube feed or parenteral nutrition
- •Diagnosed with an eating disorder such as bulimia or binge eating
- •Any acute gastrointestinal disease within 2 weeks prior to study entry
- •History of Cancer
- •Clinically significant cardiac disease or endocrine abnormalities
- •Untreated major psychiatric disorder
- •History of bariatric surgery
- •Known HIV positive
- •Serum creatinine of greater than or equal to 1.5 mg per dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values greater than or equal to 2.5 X Upper Limit of Normal (ULN).
结局指标
主要结局
Effects assessed in terms of maintenance and/or mean change in blood glucose (FBG, PPBG) from baseline to end of treatment i.e. 12 weeks, between the two test biscuit groups and compare to placebo group
时间窗: At week 12
次要结局
- Maintenance and /or mean change in(HbA1c, QUICKI, body weight, waist circumference, BMI, lipid parameters (HDL, LDL, VLDL and TG),)
研究者
研究点 (1)
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