CTRI/2012/02/002398
Completed
Phase 4
Epidemiological study to evaluate the dietary composition of Indian type-2 diabetic patients compared to non-diabetic population - STARCH
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Diabetic population and non diabetic populaion
- Sponsor
- Bayer Pharmaceuticals
- Enrollment
- 800
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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, Parkinsonâ??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
Outcomes
Primary Outcomes
Not specified
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