Health Condition 1: null- Obese Indian Type 2 Diabetes Mellitus Patients
Conditions
Interventions
Intervention1: Glucerna: A nutritional healthy diet supplement will be provided daily 1-2 time for a period of 90 days
Control Intervention1: Diet Counseling: Counseling on diet will be provided to on
Sponsors
Abbott Nutrition International India Abbott Healthcare Private Limited
Eligibility
Inclusion 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 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
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 pills, she should be using them for at least 3 months prior to signing the informed consent. 7. Patient has evidence or history of clinically significant hematological, renal, endocrine,pulmonary,gastrointestinal,cardiovascular,hepatic,psychiatric,neurologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing) For example Hemoglobin Patient has a platelets Patient has a WBC count 14,000/μL at screening Patient has a fasting (>=8 hours) blood glucose , >=270 mg/dL, at screening Patient has a fasting ( >=12 hours) blood LDL -cholesterol >=160 mg/dL, at screening Patient has a fasting (>=12 hours) blood Triglycerides (TG) >500 mg/dL, at screening Patient having previous history of diagnosed Diabetic ketoacidosis Patient has a documented history of peptic ul cer or endoscopy demonstrated gastritis or any significant gastro-intestinal condition within past 6 months Patient has a current history or history within past 6 months of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, stroke or any revascularization. Additionally, history of coronary artery bypasses graft or stent implantation, clinically significant peripheral vascular disease, or congestive heart failure (NYHA Classes II-IV). 12 lead electrocardiogram (ECG)demonstrating QTc >= 450 msec at screening Patient with impaired hepatic function as defined by serum levels of alanine transaminase (SGPT), aspartate transaminase (SGOT), alkaline phosphatase >= 3� ULN (Upper Limit of Normal), total bilirubin >= 1.50 x ULN in the past 1 year Patient has a history of jaundice in the past 1 year Patient has a impaired renal function, as defined by serum creatinine >= 1.4 for women and >= 1.5 for men, in the past 1 year Patient has a history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of diabetes specific nutritional supplement with dietary counseling and physical activity as per tDNA-PATh Tool Kit versus standard of medical care (dietary counseling and physical activity) on HbA1c of type 2 diabetes mellitus patients Timepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of diabetes specific nutritional supplement with dietary counseling and physical activity as per tDNA-PATh Tool Kit versus standard of medical care (dietary counseling and physical activity) on Type 2 diabetes mellitus patients on following parameters Fasting Plasma Glucose (FPG) Postprandial Plasma Glucose (PPG) Body Weight BMI Waist Circumference Lipid Profile(Total cholesterol, LDL, HDL, TG) Quality of Life Instrument for Diabetics (QOLID) Satiety ScoresTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactMrs Sudha Vasudevan
Madras Diabetes Research Foundation
Outcome results
None listed