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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01450592
First received: October 10, 2011
Last updated: December 26, 2013
Last verified: December 2013
  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.


Condition Intervention
Metabolic Disease
Diabetes Mellitus
Other: No drug

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epidemiological Study to Evaluate the Dietary Composition of Indian Type-2 Diabetic Patients Compared to Non-diabetic Population

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of total energy intake as carbohydrate by Indian diabetic population [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Percentage of diabetics population who follows diet plan [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Percentage of diabetic population with glycaemic control [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 796
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Other: No drug
Diabetic Population
Group 2 Other: No drug
Non-Diabetic Population

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type-2 diabetic and non-diabetic population

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450592

Locations
India
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01450592     History of Changes
Other Study ID Numbers: 15922, NN1120IN
Study First Received: October 10, 2011
Last Updated: December 26, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Bayer:
Carbohydrate, Dietary

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014