Study To Assess the Dietary Carbohydrate Content of Indian Diabetic Population (STARCH)

December 26, 2013 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

796

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Many Locations, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type-2 diabetic and non-diabetic population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Other: No drug
Diabetic Population
Other: No drug
Non-Diabetic Population
Group 2
Other: No drug
Diabetic Population
Other: No drug
Non-Diabetic Population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of total energy intake as carbohydrate by Indian diabetic population
Time Frame: 1 day
1 day
Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population
Time Frame: 1 day
1 day
Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population
Time Frame: 1 day
1 day
Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population
Time Frame: 1 day
1 day
Percentage of diabetics population who follows diet plan
Time Frame: 1 day
1 day
Percentage of diabetic population with glycaemic control
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 10, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 26, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15922
  • NN1120IN (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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