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Study To Assess the Dietary Carbohydrate Content of Indian Diabetic Population

NCT ID: NCT01450592

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

796 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Disease Diabetes Mellitus

Keywords

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Carbohydrate, Dietary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

No drug

Intervention Type OTHER

Diabetic Population

Group 2

No drug

Intervention Type OTHER

Non-Diabetic Population

Interventions

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No drug

Diabetic Population

Intervention Type OTHER

No drug

Non-Diabetic Population

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , India

Site Status

Countries

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India

References

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Joshi SR, Bhansali A, Bajaj S, Banzal SS, Dharmalingam M, Gupta S, Mukhopadhyay S, Shah PR, Sahay R, Sarkar S, Manjrekar PV, Rathod RT, Joshi SS. Results from a dietary survey in an Indian T2DM population: a STARCH study. BMJ Open. 2014 Oct 31;4(10):e005138. doi: 10.1136/bmjopen-2014-005138.

Reference Type DERIVED
PMID: 25361834 (View on PubMed)

Other Identifiers

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NN1120IN

Identifier Type: OTHER

Identifier Source: secondary_id

15922

Identifier Type: -

Identifier Source: org_study_id