Metabolic DiseaseSTARCHNCT01450592
Study To Assess the Dietary Carbohydrate Content of Indian Diabetic Population
An observational study of Metabolic Disease and Diabetes Mellitus, run by Bayer at 1 site in India.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Disease, Diabetes Mellitus
- What is being tested?
- No drug
- How many people
- 796 participants
- Where
- 1 siteIndia
- Study dates
- May 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type-2 diabetic and non-diabetic population
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Metabolic Disease, Diabetes Mellitus
- Being tested
- No drug
- Keywords
- Carbohydrate, Dietary
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
Diabetic Population
No drugOther
Non-Diabetic Population
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: No drug | |
| Group 2 | Not described Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total energy intake as carbohydrate by Indian diabetic population
Measured: 1 day
Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population
Measured: 1 day
Secondary outcomes (5)
Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population
Measured: 1 day
Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population
Measured: 1 day
Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population
Measured: 1 day
Percentage of diabetics population who follows diet plan
Measured: 1 day
Percentage of diabetic population with glycaemic control
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450592
- Sponsor's protocol ID
- 15922
- Other IDs
- NN1120IN
- Acronym
- STARCH
- Status last verified
- Dec 2013
- First submitted
- 10 Oct 2011
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25361834
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study to Evaluate the Dietary Composition of Indian Type-2 Diabetic Patients Compared to Non-diabetic Population
- ClinicalTrials.gov ID
- NCT01450592
- Acronym / sponsor ID
- STARCH / 15922
- Conditions
- Metabolic Disease, Diabetes Mellitus
- Keywords
- Carbohydrate, Dietary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No drug |
| Group 2 | – | Other: No drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type-2 diabetic and non-diabetic population
Key inclusion criteria (9 listed)
- 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
- Indian non-diabetic population who are not following any diet plan or dietary advice
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drugDiabetic Population | Other | Group 1 |
| No drugNon-Diabetic Population | Other | Group 2 |
Primary outcome
Percentage of total energy intake as carbohydrate by Indian diabetic population
Time frame: 1 day
Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population
Time frame: 1 day
5 secondary outcomes
Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population
Time frame: 1 day
Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population
Time frame: 1 day
Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic population
Time frame: 1 day
Percentage of diabetics population who follows diet plan
Time frame: 1 day
Percentage of diabetic population with glycaemic control
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Derived from this study: PubMed 25361834Joshi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease and Diabetes Mellitus, run by Bayer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of total energy intake as carbohydrate by Indian diabetic population (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2013.