Trial Condition(s):
Metabolic disease, Diabetes Mellitus
Study To Assess the dietary carbohydrate content of Indian diabetic population (STARCH)
Bayer Identifier:
15922
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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, 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Epidemiological study to evaluate the dietary composition of Indian type-2 diabetic patients compared to non-diabetic population
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Percentage of total energy intake as carbohydrate by Indian diabetic populationTimeframe: 1 day
- Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic populationTimeframe: 1 day
Secondary Outcome
- Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic populationTimeframe: 1 day
- Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic populationTimeframe: 1 day
- Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic populationTimeframe: 1 day
- Percentage of diabetics population who follows diet planTimeframe: 1 day
- Percentage of diabetic population with glycaemic controlTimeframe: 1 day
Additional Information
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