A prospective, comparative study to evaluate the glycemic index of test (food)products: Rice 1, Rice 2, Rice 3 and Rice 4 in controlled type 2 diabetic patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Marico Ltd
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the glycemic index of test food ( 4 rice
研究概览
简要总结
This study is a prospective, comparative study to evaluate the glycemic index of test (food) products: Rice 1, Rice 2, Rice 3 and Rice 4 in controlled type 2 diabetic patients that will be conducted in one centre in India. The objective of the study is to evaluate the glycemic index of test food ( 04 rice samples). Selected patients will be asked to come to the trial site after 10-12 hours of overnight fast. Each patient will receive the reference food on three occasions and each rice sample on eleven occasions on separate days in a random order. Each patient will serve as his or her own control. Capillary blood samples will be collected and blood glucose readings would be noted down as per the glucometer at ten different time points i.e. -5mins , 0mins (will be averaged to obtain Fasting Blood glucose reading), 15mins, 30mins, 45mins, 60mins, 90mins, 120mins, 150mins & 180mins during each visit for 35 days of study period. Blood glucose level will be used to determine glycemic index. Subject completes all his/her visit within 35 days & after completing the final visit glycemic index will be assessed. Blood sample will be taken for testing blood glucose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed to be suffering from Type 2 diabetes mellitus taking oral hypoglycemic drugs or insulin and with blood sugar stabilized within normal range(Fasting sugar level < 110 mg/dl & Postprandial sugar level < 140 mg/dl )
- •Patients of either sex in the age group between 30 to 60 years.
- •Patients confirmed to be in normal health status by performing the below mentioned investigations A) clinical examination B) Haematological investigations: Hemoglobin, Complete blood count & Erythrocyte sedimentation rate C) Biochemical investigations: Alanine transaminase, aspartate transaminase, serum proteins, Albumin globulin ratio, serum bilirubin,fasting blood glucose, postprandial blood glucose level, blood urea nitrogen and serum creatinine D) X-ray chest E) Electrocardiogram F)Urine pregnancy test for female patients G) HIV 1, 2 & HBsAg testing All the above mentioned investigations must be normal (parameters tested in all investigations must be in the normal range ± 5% as reflected in the reports)
- •Patient with body mass index of >18.5kg/m 2 and < 25 kg/m2 [1]
- •Patient with HbA1C < 7%
- •Subjects who provide a written informed consent to abide by the study requirements.
排除标准
- •Patients diagnosed as Type 1 diabetes mellitus 2.Presence of any clinically significant abnormal results of investigations done at screening e.g. significant abnormality of Liver Function Test (more than 2.5 times upper limit of normal), & Renal Function Test (more than 1.5 times upper limit of normal),fasting glucose >110 mg% , postprandial blood sugar level > 140 mg% 3.Patients in the last one month with A) any major illness requiring hospitalization B) acute exacerbation of any ongoing chronic medical illness e.g.Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •Medications requiring change of doses for treatment of the chronic illness
- •Patients suffering from severe cardiac, renal, liver or any other organ impairment.
- •History of seizures, epilepsy or anyneurological disorders.
- •Consumption of alcohol / tobacco products within 48 hours prior to dosing of test /reference product and during the study period (17 days to 33 days )
- •Use of any recreational drug or a history of drug addiction.
- •Receipt of any other prescription drug or over the counter (OTC) drugs for more than 24 hours within two weeks prior to receiving the first dose of test or food product
- •An unusual diet, special diet, e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food product and throughout subject’s participation in the study.
- •Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
- •Patient with any history of food allergy
- •Pregnant or lactating females.
结局指标
主要结局
To evaluate the glycemic index of test food ( 4 rice
时间窗: Approximately 35 Days
samples)
时间窗: Approximately 35 Days
次要结局
未报告次要终点