Effect of a Nutritional Supplement drink on the glycemic response among type 2 diabetes patients

Not Applicable

• Conditions: Health Condition 1: null- Obese Indian Type 2 Diabetes Mellitus Patients

• Registration Number: CTRI/2015/04/005693
• Lead Sponsor: Abbott Nutrition International India Abbott Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 120

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

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

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 >= 3Ã? 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>Timepoint: 90 days

Secondary Outcome Measures

Name	Time	Method
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 <br/ ><br> <br/ ><br> <br/ ><br>Fasting Plasma Glucose (FPG) <br/ ><br>Postprandial Plasma Glucose (PPG) <br/ ><br>Body Weight <br/ ><br>BMI <br/ ><br>Waist Circumference <br/ ><br>Lipid Profile(Total <br/ ><br>cholesterol, LDL, HDL, TG) <br/ ><br>Quality of Life Instrument for Diabetics (QOLID) <br/ ><br>Satiety ScoresTimepoint: 90 days