Effect of bitter gourd clinical trial in prediabetics: blind, randomised, cross over trial in India

Transcription

1 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

2 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

3 Amount (INR) Monthly Medical Expenditure 1,600 Male= ,400 Female=94 1,200 1,000 1,020 1, Medicine Doctor visits Blood analysis Total expenditure

4 CLASSIFICATION ACCORDING TO BMI OBESE SUBJECTS Pre-obese ( ) 44.7% 15.9% Obese (>30) 11.3% 2% 2.6% Obese class III (>40) Obese class II ( ) 36.7% Normal range 2% 0.7% Mild thinness Moderate thinness Obese class I ( )

5 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

6 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

7 Objectives Assess the prevalence of pre diabetics in the age group of 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

8 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

9 Ethical Clearance Clinical Trial Registry Of India (CTRI)of ICMR registration number - CTRI/2013/06/ Institutional Human Ethics Committee approval No AUW/IHEC-2013 AP-01

10 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 Sep;53: 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

11 Sex PRE DIABETICS SCREENED Screened by IDRS High risk vulnerable ( 60 ) Prediabetics (FBG mg/dl) Willing to participate in clinical trials No % No % No % No % Male Female Total

12 Inclusive Criteria Age: Sex: > 25 yrs Male and Female Fasting Blood Glucose: mg/dl HbA1c between: % Non alcoholics Willingness to participate in feeding trials and give written consent

13 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

14 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

15 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

16 SALIENT FINDINGS

17 Age (yrs) AGE GROUP OF THE SELECTED PREDIABETICS Male Female Total No % No % No % < Total

18 AREA OF RESIDENCE Area No % Urban Semi urban Rural TYPE OF ACTIVITY Activity No % Sedentary Moderate Heavy 9 10

19 Economically week Low Middle High INCOME LEVEL 9 % 28 % 12 % 41 %

20 DIETARY PATTERN Vegetarian 9% Non-vegetarian 89% Ova Vegetarian 2%

21 Meal Pattern Meal pattern No Per cent 2 meal/day meal/day > 3 meal Hot beverages 95.6%

22 EXERCISE Walking 20% Exercise 33.3 % Gardening and others 3.3 % Yoga 12.2 %

23 Weight (Kg) Weight (Kg) BODY WEIGHT Mary Drink John Drink Initial Final 66.5 Male Female

24 FBG level mg/dl Mean FBG of the Prediabetics FBG level mg/dl Male Mary John Weeks Female Mary John Weeks

25 % Glycosylated Hemoglobin Initial Final Mary John

26 mg/dl mg/dl LIPID PROFILE 39.6 Mary drink Initial Final John drink Initial Final

27 CONCLUSION Prevalence of prediabetics is 12.6 per cent Incidence of prediabetics is high among 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

28 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

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