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STARCH: Study To Assess the dietaRy CarboHydrate content of Indian diabetic populatio

Phase 4
Completed
Conditions
Health Condition 1: null- Diabetic population and non diabetic populaion
Registration Number
CTRI/2012/02/002398
Lead Sponsor
Bayer Pharmaceuticals
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
800
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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of total energy intake as carbohydrate by Indian diabetic population <br/ ><br>Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic populationTimepoint: Time Frame: 1 day <br/ ><br>Time Frame: 1 day
Secondary Outcome Measures
NameTimeMethod
Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population <br/ ><br>Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population <br/ ><br>Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population <br/ ><br>Percentage of diabetics population who follows diet plan <br/ ><br>Percent of diabetic population with glycaemic controlTimepoint: Time Frame: 1 day
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