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CTRI Number  CTRI/2015/04/005693 [Registered on: 10/04/2015] Trial Registered Prospectively
Last Modified On: 10/04/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of a Nutritional Supplement drink on the glycemic response among type 2 diabetes patients 
Scientific Title of Study   A Pilot Study to Evaluate the Effectiveness of Transcultural Diabetes Nutrition Algorithm (tDNA)on Glycemic Control and Quality Of Life in Obese Indian Type 2 Diabetes Mellitus PatientsInvestigator Initiated Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Mohan 
Designation  President and Chief of Diabetes Research 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition and Dietetics Research Madras Diabetes Research Foundation No 4 Conran Smith Road Gopalapuram Chennai

Chennai
TAMIL NADU
600086
India 
Phone  914439988816  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query  
Name  Dr V Mohan 
Designation  President and Chief of Diabetes Research 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition and Dietetics Research Madras Diabetes Research Foundation No 4 Conran Smith Road Gopalapuram Chennai

Chennai
TAMIL NADU
600086
India 
Phone  914439988816  
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Public Query  
Name  Mrs Sudha Vasudevan 
Designation  Sr Scientist and Head 
Affiliation  Madras Diabetes Research Foundation 
Address  Department of Foods Nutrition and Dietetics Research Madras Diabetes Research Foundation No 4 Conran Smith Road Gopalapuram Chennai

Chennai
TAMIL NADU
600086
India 
Phone  914439988816  
Fax    
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
Abbott Nutrition International India, Abbott Healthcare Private Limited 
 
Primary Sponsor  
Name  Abbott Nutrition International India Abbott Healthcare Private Limited 
Address  4 Corporate Park Sion-Trombay Road Mumbai 400 071 INDIA  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Sudha Vasudevan  Madras Diabetes Research Foundation  No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU 		 91443998816

s2r_7@mdrf.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Madras Diabetes Research Foundation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Obese Indian Type 2 Diabetes Mellitus Patients ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diet Counseling  Counseling on diet will be provided to one arm of the study subjects participating for a duration of 90 days 
Intervention  Glucerna  A nutritional healthy diet supplement will be provided daily 1-2 time for a period of 90 days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 ≥ 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 of acquired immune deficiency syndrom e (AIDS) or human immunodeficiency virus (HIV) infection

Patient has a history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ
damage, e.g. proliferative retinopathy and/or macular edema, creatinine clearance ≤60 mL/min based on the Cockcroft -Gault equation, diabetic
neuropathy complicated by neuropathic ulcers

Patient has a history of illicit drug or alcohol abuse within last 1 year

8. Patients on therapy with the following drugs
will not be permitted to participate in
the trial: glucocorticoids, pentamidine, nicotinic acid, diazoxide, β-adrenergic
agonists, hydantoins, asparaginase, α-interferon, antipsychotics (atypicals and others), epinephrine, anti-secretory agents, cyclosporine,
tacrolimus, digoxin,quinine, salicylates, multivitamins, high-ceiling diuretics, appetite stimulants,progestational agents, growth hormones, other anabolic agents, sibutramine,
orlistat, rimonabant and drugs which will affect folate metabolism, currently or within past 3 months from the time of informed consent.

9.Patient has a history of any condition possibly affecting absorption of study product.
10.Patient has received any investigational drug within 30 days (or 5 half-lives of the investigational drug,whichever is greater) prior to study start
11. Patient has any major or minor surgery within 30 days prior to screening
12. Patient has a history of malignancy in the past 1 year 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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
 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
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 Scores 		 90 days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The study results may be published in Indian /International Journals. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
India leads the world, second only to China, with the largest number of subjects with diabetes. In India, it is observed that at least 2% of Indian population dies of diabetes and itscomplications every year and the deaths from diabetes are estimated to increase by 35% by 2015. Although there is an increase in the prevalence of type 1 diabetes also, the major driver of the epidemic is the more common form, type 2 diabetes, which accounts for morethan 90 per cent of all diabetes cases.Currently in India there are 62 million people with diabetes and 77 million people with pre-diabetes. Studies on migrant Indians across the globe have shown that Asian Indians have an increased risk for developing type 2 diabetes and related metabolic abnormalities compared to other ethnic groups. Despite having lower prevalence of obesity as defined by body mass index (BMI), Asian Indians tend to have greater   waist circumference and waist to hip ratios thus having a greater degree of central obesity. These findings suggest that Asian Indians are more prone to diabetes and related metabolic  abnormalities. Also the rapidly changing life style such as consumption of fast foods and sedentary behavior are responsible for the dramatic rise in the prevalence of type 2 diabetes and  related disorders like obesity, hypertension and the metabolic syndrome.Recently it was shown that half of the adult Indians from rural and urban areas were inactive and less than  10% of Indians engage in leisure time physical activity. Treatment of diabetes requires comprehensive care involving use of anti-diabetic medications and modification of diet and lifestyle provided by a multidisciplinary team (physicians, nurses and nutritionists).Dietary modifications that limit hyperglycemia following a meal are crucial in limiting the complications of diabetes. Studies in patients with type 2 diabetes have combined dietary intervention with exercise and lifestyle management programme. As per Meta Analysis of such studies dietary  intervention produced weight loss coupled with improvements in metabolic control compared to other lifestyle changes. Hence, the diet is considered a cornerstone of diabetes care, yet it  as been reported to be the major area of poor compliance among diabetic patients.In order to ensure dietary compliance in diabetic patients, it maybe useful to provide a ready to use formula which plays a supplementary role to drug treatment to prevent extreme blood-glucose excursions. It is observed that Diabetes-specific formulas not only significantly reduce  postprandial rise in blood glucose, but also reduce the requirement of insulin (26 –71% lower), with no significant effect on HDL, total cholesterol, or triglyceride concentrations. It is also  observed that compared to standard nutritional formula, diabetes-specific formula results in fewer complications. A 5–10% reduction in weight dramatically decreases the risk of  developing type 2 diabetes in overweight /obese persons with impaired glucose tolerance and improves glycemic control in individuals who already have diabetes and also lowers blood pressure, LDL cholesterol, and triglyceride. However, studies evaluating the effect of Diabetes Specific Nutritional Supplement on glycemic control,body weight and Quality of life in Indian  type 2 Diabetes patients have not been conducted so far. Thus, the purpose of this study is to demonstrate that dietary counseling and physical activity along with diabetes specific nutritional supplement forms an important part of the diabetes management in type 2 diabetes mellitus patients who are obese.

The initiative called transcultural diabetes-specific  nutrition algorithm (tDNA) was steered under stewardship of Dr. Jeffrey I.Mechanick involving other experts from across the world.

The group in their deliberations reiterated a known fact that Indians have lower body mass index (BMI) than westerners and also that they are inherently different  from their western  counterparts on
1.Abdominal fat being higher ( “ thin fat” Indian)
2.Insulin resistance and hyperinsulinemia
3.Higher levels of C-reactive protein
4.Lower levels of adiponectin
5.Characteristic dyslipedemia( low HDL,high triglycerides and VLDL)
6.Increased susceptibility to coronary artery disease.Taking into account above factors and considering India as a mix of different cultures,geographies,ethnicity, eating patterns below nodal points were identified as areas for customisation specific to India and they are

1.Body Mass Indices criteria to define overweight, obesity etc
2.Recommendations on physical activity
3.Different BMI cut off criteria for obesity management like initiation of pharmacotherapy and bariatric surgery
4.Different waist circumference values to define disease risk
5.Region specific diet charts to cater to varied idiosyncrasies of Indian palate and address current eating pattern like;
a. oil rich diets across many regions of India
b. already higher consumption of salt due to extensive use of pickels, papad,lassi, chaas etc.
c.Higher consumption of refined grains,fast foods or energy dense foodsThe above points were customised based on two consensus guidelines;
1.Consensus Dietary Guidelines for Healthy Living and Prevention of Obesity, the Metabolic Syndrome, Diabetes, and Related Disorders in Asian Indians
2. Consensus Physical Activity Guidelines for Asian Indians
This algorithm is intended to 1) increase awareness of the benefits of nutritional interventions for patients with T2D and pre-diabetes; 2) encourage healthy dietary patterns that accommodate regional differences in genetic factors, lifestyles, foods, and cultures; 3) enhance the implementation of existing Clinical Practice Guidelines for T2D and pre-diabetes management; and 4) simplify nutritional therapy for ease of application and portability Hence the pilot study has been designed to evaluate the effect of the customised diabetes specific nutritional supplement along with dietary counseling and physical activity as per tDNA-PATh Tool Kit versus standard of medical care (dietary counseling and physical activity) in patients with type 2 diabetes who are obese .

This is a randomized,prospective,open-label,comparative,single center, investigator initiated pilot study that will be conducted in 120 obese patients with type 2diabetes
 
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