An open-label, randomized, crossover, pilot study to assess the efficacy of Nutren diabetes, in maintenance of blood glucose level in patients with type 2 diabetes (T2DM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nestle
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary efficacy outcome for this study is reduction in postprandial blood glucose level over stipulated time points (30, 60, 90, 120, and 180 minutes) form baseline (0 min). This parameter is considered one of the standards for the determination of blood glucose control.
研究概览
简要总结
This will be an open-label, randomized, single-center, 2-period, cross over, pilot study in patients with T2DM to determine the efficacy of Nutren diabetes, a nutritional supplement, in maintenance of blood glucose level in patients with T2DM.
The study will consist of a Pre-Treatment Phase and a Treatment Phase. The Pre-Treatment Phase will consist of Screening Period followed by a Run-in Period. During the Screening Period (Day -14 to Day -8) the patients will be evaluated to determine if they meet the Inclusion/Exclusion criteria. During the Run-in period (Day -7 to Day -1) the patients will be advised on the diet and exercise to be followed. The Run-in Period is included in this study to ensure that all patients receive the same nutrition counseling and advise in order to bring homogeneity in the study. At the end of Run-in Period the patients will be randomized to one of the study groups.
The Treatment Phase will consist of 2 periods of 1 day each, separated by a washout period of 1 week and a follow up period of 2 days. During each period, the patients will be confined to the clinic and will be administered either the test product or isocaloric diet as per the randomization schedule. The test product will be given as a meal replacement in the morning after overnight fast; only water will be allowed. Blood samples will be collected for estimation of blood glucose level and triglyceride levels at stipulated time points. The subjects will also be asked to fill a questionnaire on Day 1 and Day 8 for assessing the patient’s sensations of hunger, satiety, and other appetite sensations as per schedule of assessments. Subjects will be released from the clinic on same day after completion of all study related procedures. The patients will be followed up through telephone for safety assessments at the end of Period 2 for 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patient has a known history of diabetes (T2DM) and is currently on antihyperglycemic drugs.
- •2.The patient has good diabetes control defined as baseline HbA1c levels of 7.0-9.0% 3.The patient is male or female, and is ≥35 and ≤60 years of age 4.The patient is capable of understanding and complying with the protocol requirements 5.The patient signs a written, informed consent form prior to the initiation of any study procedures 6.The patient has a fasting blood glucose less than 180 mg 7.The patient has a stable weight; no loss/gain of a maximum of 10% of their body weight within the past 6 months.
排除标准
- •1.The patient has symptoms of very poor diabetes control defined as HbA1c > 9%.
- •2.The patient is on insulin therapy for management of diabetes.
- •3.The patient has serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse.
- •4.The patient has participated in any other investigational study within 30 days prior to initiation of the study.
- •5.The patient is currently using other diabetic nutritional supplements sharing the same mechanism of action as Nutren Diabetes.
- •6.The patient is a study site employee, or is an immediate family member (ie, parent, child, and sibling) of a study site employee, involved in conduct of this study.
- •7.The patient has history of hypersensitivity to any of the ingredients of Nutren.
- •8.The patient has history of hypersensitivity to any of the ingredients of test meal.
- •9.If the patient is female, the patient is pregnant or lactating.
- •10.The patient has any condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for the study.
- •11.The patient is unable to understand to comply with the instructions.
- •12.The patient is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
结局指标
主要结局
The primary efficacy outcome for this study is reduction in postprandial blood glucose level over stipulated time points (30, 60, 90, 120, and 180 minutes) form baseline (0 min). This parameter is considered one of the standards for the determination of blood glucose control.
时间窗: 0, 30, 60, 90, 120, and 180 minutes
次要结局
- The secondary efficacy outcome for this study is change in insulin level over stipulated time points (30, 60, 90, 120, and 180 minutes) from baseline (0 min) and triglycerides level at 120 min from fasting state as the intake of any food product is directly related the lipid content. Also subjective sensations of hunger, satiety, and other appetite sensations will be assessed for the patients using a VAS questionnaire.(0, 30, 60, 120 and 180 minutes.)