Effect of bitter gourd clinical trial in prediabetics: blind, randomised, cross over trial in India Dr.M. Amirthaveni Subramanian & Dr.S.Premakumari Department of Food Science and Nutrition Avinashilingam Institute for Home Science and Higher Education for Women Coimbatore-641043
Need for the study Each year about 7 M people develop diabetes Diabetes is the 4 th leading cause of global death disease Every 10 seconds a person dies from diabetes related causes Number of people living with diabetes is expected to rise from 366 million in 2011 to 552 million by 2030, if no urgent action is taken
Amount (INR) Monthly Medical Expenditure 1,600 Male=56 1507 1534 1,400 Female=94 1,200 1,000 1,020 1,008 800 600 400 200 230 229 258 296 0 Medicine Doctor visits Blood analysis Total expenditure
CLASSIFICATION ACCORDING TO BMI OBESE SUBJECTS Pre-obese (25-29.9) 44.7% 15.9% Obese (>30) 11.3% 2% 2.6% Obese class III (>40) Obese class II (35-39.9) 36.7% Normal range 2% 0.7% Mild thinness Moderate thinness Obese class I (30-34.9)
Dietary and Life style modifications are the main stay interventions to prevent or delay the onset of diabetes In Developing countries - 80 % diabetics use traditional medicines Bitter gourd is a traditional medicine and its medicinal value has been attributed to its high antioxidant properties due to charantin, polypeptide P, phenols, flavonoids, isoflavones, terpenes, anthoquinones and glucosinolates
Hypoglycaemic effects of bitter gourd extracts have been demonstrated in various animal models of insulin resistance Hence the study is undertaken with the following objectives
Objectives Assess the prevalence of pre diabetics in the age group of 25-60 yrs Assess the socio- economic, demographic information, dietary and lifestyle pattern of the selected pre diabetics Supplement bitter gourd juice to selected pre diabetic subjects Evaluate the impact of intervention through anthropometric and biochemical parameters
Research Design Phase - I Phase - II Phase - III Phase - IV Phase - V Screening of prediabetics Conduct socio economic and dietary survey Clinical trial with prediabetcis Evaluation of impact-anthropometric and biochemical parameters Nutrition and health education
Ethical Clearance Clinical Trial Registry Of India (CTRI)of ICMR registration number - CTRI/2013/06/003759 Institutional Human Ethics Committee approval No AUW/IHEC-2013 AP-01
Phase I-Screening of prediabetics *Mohan V, Deepa R, Deepa M, Somannavar S, Datta M., A simplified Indian Diabetes Risk Score for screening for undiagnosed diabetic subjects..j Assoc Physicians India. 2005 Sep;53:759-63. Selection of subjects Govt. & Private Industries Male & Female (>25-60yrs) N-948 Pre inclusion criteria IDRS * IDRS 60 WC > 80 cm for women and > 94 cm for men BMI> 27 kg/m²
Sex PRE DIABETICS SCREENED Screened by IDRS High risk vulnerable ( 60 ) Prediabetics (FBG 100-125 mg/dl) Willing to participate in clinical trials No % No % No % No % Male 540 57 189 35 64 11.9 53 9.8 Female 408 43 148 36.3 56 13.7 37 9.1 Total 948 100 337 35.5 120 12.6 90 9.5
Inclusive Criteria Age: Sex: > 25 yrs Male and Female Fasting Blood Glucose: 100-125 mg/dl HbA1c between: 5.7-7.4% Non alcoholics Willingness to participate in feeding trials and give written consent
Exclusive Criteria Presence of complications & disorders Taking medication High blood pressure (>160/>100) and low blood pressure (<90/<60) Pregnancy/ planning for pregnancy/ breast feeding
Phase II-Collection of Data Socio economic status Dietary and lifestyle pattern Questionnaire method Bitter gourd-awareness and consumption Personal and family history of diabetes
Phase III-Overview on the study design, time frame and types of assessment Venous blood samples for FPG, HbA1c, Lipid profile, Body composition, Blood pressure and Anthropometrics Capillary blood samples for FPG and Anthropometrics
SALIENT FINDINGS
Age (yrs) AGE GROUP OF THE SELECTED PREDIABETICS Male Female Total No % No % No % <30 2 2.2 7 7.7 9 10 31-40 19 21.1 15 16.6 34 37.7 41-50 23 25.5 10 11.1 33 36.6 51-60 9 10 5 5.5 14 15.5 Total 53 58.8 37 41.1 90 100
AREA OF RESIDENCE Area No % Urban 54 60 Semi urban 19 21.1 Rural 17 18.9 TYPE OF ACTIVITY Activity No % Sedentary 44 48.9 Moderate 37 41.1 Heavy 9 10
Economically week Low Middle High INCOME LEVEL 9 % 28 % 12 % 41 %
DIETARY PATTERN Vegetarian 9% Non-vegetarian 89% Ova Vegetarian 2%
Meal Pattern Meal pattern No Per cent 2 meal/day 20 22.2 3 meal/day 69 76.7 > 3 meal 1 1.1 Hot beverages 95.6%
EXERCISE Walking 20% Exercise 33.3 % Gardening and others 3.3 % Yoga 12.2 %
Weight (Kg) Weight (Kg) BODY WEIGHT Mary Drink John Drink 70 69.5 69 69.9 68.8 69.3 Initial 68.5 68 67.5 67 67.9 Final 66.5 Male Female
FBG level mg/dl Mean FBG of the Prediabetics FBG level mg/dl 115 110 113.1 Male Mary John 105 100 95 101.9 103.2 99.6 90 1 2 3 4 5 6 7 8 Weeks 115 110 105 106.2 105.2 Female Mary John 105.2 100 99.7 95 90 1 2 3 4 5 6 7 8 Weeks
% Glycosylated Hemoglobin 7 6.5 6 5.5 5.5 6.03 6.6 5.7 Initial Final 5 4.5 Mary John
mg/dl mg/dl 200 150 100 50 0 184 186 131 117 LIPID PROFILE 39.6 Mary drink 120 41.5 62.8 23.3 24.2 Initial Final 200 191 184 132.6 145.2 John drink 125.2116.7 100 39.7 38.4 26.1 29 0 Initial Final
CONCLUSION Prevalence of prediabetics is 12.6 per cent Incidence of prediabetics is high among 30-50 yrs of age Among the selected prediabetics only 33.3 % are doing exercise regularly Consumption of mary drink resulted in better reduction of body weight, FBG and LDL-C that the John drink
Acknowledgement The authors gratefully acknowledge the support rendered by Federal Ministry for Economic cooperation and Development, Germany AVRDC- The World Vegetable Centre, Taiwan All the Project Collaborators Subjects of the Clinical Trial