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

Not yet recruiting

• Conditions: 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

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-15
• Last Update Posted: 2015-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• 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 ≥ 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.

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	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	Fasting Plasma Glucose (FPG)

Trial Locations

Locations (1)

Madras Diabetes Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

Madras Diabetes Research Foundation

🇮🇳Chennai, TAMIL NADU, India

Mrs Sudha Vasudevan

Principal investigator

91443998816

s2r_7@mdrf.in