check_circleStudy Completed
Metabolic disease, Diabetes Mellitus
Bayer Identifier:
15922
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study To Assess the dietary carbohydrate content of Indian diabetic population
Trial 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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
796Trial Dates
May 2012 - September 2012Phase
N/ACould I Receive a placebo
NoProducts
No DrugAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, India |
Primary Outcome
- Percentage of total energy intake as carbohydrate by Indian diabetic populationdate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
- Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic populationdate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic populationdate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
- Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic populationdate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
- Difference in the percentage of total energy intake as proteins & fats by diabetics versus non-diabetic populationdate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
- Percentage of diabetics population who follows diet plandate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
- Percentage of diabetic population with glycaemic controldate_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A