ACTRN12614001302640已完成3 期
A double blinded, randomised controlled trial to determinea) the efficacy of alpha-cyclodextrin on cholesterol control, andb) the efficacy of Compound K on glycaemic controlin overweight and obese participants with pre-diabetes.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •*Aged 18 years or over
- •*BMI greater than or equal to 25
- •*Pre-diabetes (based on ADA guidelines, determined by bloods at the screening visit or 6 months prior to Screening):
- •- a fasting plasma glucose greater than or equal to 5.6 mmol/L AND/OR
- •- 2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 7.8 mmol/L AND/OR
- •- HbA1c greater than or equal to 5.7%
排除标准
- •*Type 2 diabetes criteria are based on ADA guidelines. Participants will be excluded from the study if they have:
- •- a fasting plasma glucose greater than or equal to 7.0 mmol/L AND/OR
- •- 2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 11.1 mmol/L AND/OR
- •- HbA1c greater than or equal to 6.5%
- •*Use of lipid lowering medication
- •*Use of anti-diabetic medications for pre-diabetes
- •*Type 1 diabetes
- •*Unstable angina or recent onset of cardiovascular disease (within 1 month of screening)
- •*Bariatric surgery
- •*A history of significant liver, kidney or gastrointestinal disease AND/OR
- •- ALT or AST > 2.5 times upper limit of normal
- •- serum creatinine > 1.5 times upper limit of normal or
- •- eGFR < 60ml/min/1.73m^2 or presence of microalbuminuria
- •*Chronic diarrhoea, bowel motility problems, or other conditions that could affect intestinal fat absorption
- •*Untreated thyroid disease
- •*Greater than 10% change in body weight over the past 3 months
- •*Alcohol or illicit drug abuse
- •*Pregnant or breastfeeding women, and women who might be planning pregnancy during the duration of the study
- •*Use of weight loss medications and other drugs that may affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids
- •*Taking the following medications which may show reduced absorption of the investigational products: antibiotics, anticoagulants, anticonvulsants, antiarrhythmics, immunosuppressants, or any other drug that is necessary to take with a meal. Short-term and prophylactic antibiotics may be taken during study participation for up to 14 days, but they should be taken at least 2 hours apart from the study drug
- •*Commencement of a new prescription medication within 3 months of screening or change in dose regimen of a prescription medication within 1 month of screening
- •*A history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and participants in remission for > 5 years prior to screening remain eligible]
- •*Inability to read and write English
- •*A history of frequently changed smoking habits, in addition to smoking cessation within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking programme at the time of screening will be eligible to start the trial after 6 months
- •*Participants may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the participant
- •*Participation in a clinical trial in the last month
- •*Unable to commit to the appointment schedule or perform the tasks required in the study.
研究者
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