Study To Assess the Dietary Carbohydrate Content of Indian Diabetic Population

Diabetes Mellitus Clinical Trial

— STARCH  

Official title:

Epidemiological Study to Evaluate the Dietary Composition of Indian Type-2 Diabetic Patients Compared to Non-diabetic Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450592
• Other study ID #: 15922
• Secondary ID: NN1120IN
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: December 26, 2013
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• No drug
Diabetic Population
• No drug
Non-Diabetic Population

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of total energy intake as carbohydrate by Indian diabetic population		1 day	No
Primary	Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population		1 day	No
Secondary	Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population		1 day	No
Secondary	Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population		1 day	No
Secondary	Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population		1 day	No
Secondary	Percentage of diabetics population who follows diet plan		1 day	No
Secondary	Percentage of diabetic population with glycaemic control		1 day	No

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