Skip to main content
OpenTrials
Completed

NCT Number: NCT01450592

Study To Assess the Dietary Carbohydrate Content of Indian 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No drug

Other

Diabetic Population

Primary outcomes

  1. Percentage of total energy intake as carbohydrate by Indian diabetic population

    Time frame: 1 day

  2. Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population

    Time frame: 1 day

Secondary outcomes

  1. Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population

    Time frame: 1 day

  2. Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population

    Time frame: 1 day

  3. Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population

    Time frame: 1 day

  4. Percentage of diabetics population who follows diet plan

    Time frame: 1 day

  5. Percentage of diabetic population with glycaemic control

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: STARCH

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.