CTRI/2015/04/005693尚未招募未知
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 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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 <=12 g/dL (males), <=10 g/dL (females)
- •Patient has a platelets <100,000 cu mm at screening
- •Patient has a WBC count <4000/μL or >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
- •Patient has a fasting (>=12 hours) blood Triglycerides (TG) >500 mg/dL, at
- •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 >= 3Ã? ULN (Upper Limit of Normal), total bilirubin >= 1.50 x ULN in the past 1
- •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
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