NCT01450592

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
796

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

October 10, 2011

Last Update Submit

December 26, 2013

Conditions

Metabolic DiseaseDiabetes Mellitus

Keywords

Carbohydrate, Dietary

Outcome Measures

Primary Outcomes (2)

  • Percentage of total energy intake as carbohydrate by Indian diabetic population

    1 day

  • Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population

    1 day

Secondary Outcomes (5)

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

    1 day

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

    1 day

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

    1 day

  • Percentage of diabetics population who follows diet plan

    1 day

  • Percentage of diabetic population with glycaemic control

    1 day

Study Arms (2)

Group 1

Other: No drug

Group 2

Other: No drug

Interventions

No drugOTHER

Diabetic Population

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type-2 diabetic and non-diabetic population

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, India

Location

Related Publications (1)

  • 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.

    PMID: 25361834DERIVED

MeSH Terms

Conditions

Metabolic DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 12, 2011

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

IN(1)