CTRI/2015/04/005693
Not yet recruiting
未知
A Pilot Study to Evaluate the Effectiveness of TransculturalDiabetes Nutrition Algorithm (tDNA)on Glycemic Control andQuality Of Life in Obese Indian Type 2 Diabetes Mellitus PatientsInvestigator Initiated Study
Abbott Nutrition International India Abbott Healthcare Private Limited0 sites120 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Abbott Nutrition International India Abbott Healthcare Private Limited
- Enrollment
- 120
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Diagnosis of Type 2 Diabetes Mellitus since at least upto 1 year, treated with stable dose
- •of oral anti\-diabetic drugs (drugs permitted include: metformin, sulfonylureas, thiazolidinediones, DPP\-IV inhibitors, GLP\-
- •1 agonists) for at least 3 month before screening
- •2\)Patients with HbA1c from 7\.5 to 8\.5 %
- •3\)Body mass index (BMI) \>\= 25 kg/m2 and \< 30 kg/m2
- •as per consensus statement for Asian Indians
- •for obesity (A.Misra JAPI Feb 2009\)
- •4\) Patient willing to provide informed consent and willing to comply with study
- •requirements
Exclusion Criteria
- •1\. Type 1Diabetes Mellitus \& Type 2 Diabetes Mellitus patient on basal or multiple injections
- •2\. Stage 2 hypertension (\>\= 160/100 mm oh Hg) with complications (as per the seventh report of the Joint National Committee on prevention,detection, evaluation, and treatment of high blood pressure)
- •3\. Allergy to one or more components of the study product or history of food allergies
- •4\. Patient receiving any diabetes specific nutritional food supplement that does not
- •include multivitamin supplements (Except Ca/Vit
- •D supplements and B complex syrups) within 15 days prior to study start.
- •5\. Patient taking any herbal/Ayurvedic Traditional preparation that could profoundly
- •affect blood glucose
- •6\. Females who are nursing / pregnant / are of child \- bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
- •. Acceptable methods of birth control include trans dermal patch, intra \- uterine devices/systems (IUDs/IUSs) and barrier methods, oral, implantable or injectable contraceptives and vasectomised partner. If the subject is on OC
Outcomes
Primary Outcomes
Not specified
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