Epidemiological study to evaluate the dietary composition of Indian type-2 diabetic patients compared to non-diabetic population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- Percentage of total energy intake as carbohydrate by Indian diabetic population
研究概览
简要总结
- Thereare few smaller studies from Southern part of India, sparing that we do not havelarger studies which documents the dietary contents of diabetic patients.
- Thereis a need to conduct dietary survey considering the diverse dietary food habitsin various parts of India.
- Interactionwith KOL also suggested that merely only percentage of diabetic populationactually follows the dietary advice (Diet Plan)
- Thepurpose of the present cross-sectional study is to comprehend the dietarypattern of diabetics and also find out how it compare with non-diabeticpopulation.
- Thisstudy results should also help us to conclusively describe the role of a-glucosidaseinhibitors like Glucobay in management protocol of diabetic patients in India,which is presently not considered as very essential for management of type-IIdiabetes mellitus.
- Inaddition, the study results should also assist to define the effective strategyto address the role of a-glucosidase inhibitors in routine management ofIndian diabetic patients
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
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: Time Frame: 1 day | Time Frame: 1 day
Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population
时间窗: Time Frame: 1 day | Time Frame: 1 day
次要结局
- Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population(Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population)