Epidemiological Study to Evaluate the Dietary Composition of Indian Type-2 Diabetic Patients Compared to Non-diabetic Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 796
- 主要终点
- Percentage of total energy intake as carbohydrate by Indian diabetic population
研究概览
简要总结
The study is designed as an interventional (as blood investigations will be done) dietary survey of diabetic & non-diabetic population sample of India to understand & compare dietary patterns among them.The study objective is to find out amount of carbohydrate content of daily diet of diabetic population study . This study does not intend to study the effect of any drugs. There will be 2 groups : Type 2 diabetics and non diabetic population. The study will begin after the study approval by ethics committee. The subject will involved after they sign the consent form. The study involves general examination of patients, collection of data like history of disease, interview by dietitian with the help of questionnaire, blood investigations (only in diabetic population only) and glycaemic control status of only diabetic population.The study is planned to be enroll 800 subjects (400 in each groups) from 10 study centers spread across India. The study data will be analyzed with appropriate statistical methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic Population
- •Patients willing to provide signed & dated informed consent and comply with study
- •Indian diabetic population diagnosed with T2DM for at least 12 months
- •Male and non pregnant female with age18 years or more
- •Non-Diabetic Population
- •Indian non-diabetic population who are not following any diet plan or dietary advice
- •Patients willing to provide signed & dated informed consent and comply with study requirements.
- •Male and non pregnant female with age 18 years or more
- •Non-diabetic population should be matched in terms of age, sex and centre
排除标准
- •Patient unwilling to comply with the study procedures.
- •Pregnant & lactating women
- •History of cardiovascular event within the previous six months.
- •Patients with specific co morbidities, which may impact the patients diet, e.g malignant diseases, advanced dementia, Parkinson's disease and others.
- •Suffering from chronic diseases including but not limited to chronic renal failure, chronic liver disease that might interfere with participation in the study as per physician discretion.
- •Patients on weight management plan e.g. low carbohydrate diet which includes dietary modifications or dietary alterations.
结局指标
主要结局
Percentage of total energy intake as carbohydrate by Indian diabetic population
时间窗: 1 day
Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population
时间窗: 1 day
次要结局
- Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population(1 day)
- Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population(1 day)
- Percentage of diabetics population who follows diet plan(1 day)
- Percentage of diabetic population with glycaemic control(1 day)
- Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population(1 day)