EVALUATION OF ANTIDIABETIC POTENTIAL OF PLANT EXTRACT(S) IN ALLOXAN INDUCED DIABETIC RATS

                                                                       STUDY PROTOCOL

EVALUATION OF ANTIDIABETIC POTENTIAL OF PLANT EXTRACT(S) IN ALLOXAN-INDUCED DIABETIC RATS

1.0  INTRODUCTION:

Diabetes mellitus is a group of syndromes characterized by hyperglycemia; altered metabolism of lipids, carbohydrates, and proteins; and an increased risk of complications from vascular disease. Diabetes mellitus, one of the most common endocrine metabolic disorders has caused significant morbidity and mortality due to microvascular (retinopathy, neuropathy, and nephropathy) and macrovascular (heart attack, stroke and peripheral vascular diseases) complications. Patients have been classified clinically as having either type 1 diabetes mellitus (insulin-dependent diabetes mellitus, IDDM), or type 2 diabetes mellitus (noninsulin-dependent diabetes mellitus, NIDDM). Type 2 diabetes mellitus, more commonly referred to as diabetes, is more prevalent and considered to be a worldwide epidemic, which is projected to affect 366 million people by 2030.

2.0  TEST SYSTEM DETAILS:

Species : Rattus norvegicus (Rat)

Strain: Wistar

Age: 8-10 weeks

Body weight : 180-200 g

Sex: Male

No. of animals: 8 /Group

3.0  ALLOCATION OF GROUPS:

Groups	Treatment	Dose; ROA (p.o.)	No. of Animals
G1	Normal Control	Normal saline or 0.25% Na-CMC	8
G2	Diabetic Control	Normal saline or 0.25% Na-CMC	8
G3	Reference Drug- Metformin	250 mpk	8
G4	Plant Extract-1	X mpk	8
G5	Plant Extract-2	XX mpk	8
G6	Plant Extract-3	XXX mpk	8

*The doses and ROA (Routes of administration) will be decided based on the type of reference drug

4.0 METHODOLOGY:

· Diabetes will be induced in Wistar rats by a single intraperitoneal injection of alloxan monohydrate in sterile normal saline to overnight fasted animals at a dose of 120 mg/kg b.w.

· The fasting blood glucose level will be determined after 2-3 days of alloxan injection.

· The rats having blood glucose levels above 200 mg/dl will be used for the study.

· The diabetic animals will be allowed free access to water, a pellet diet, and will be maintained at room temperature in plastic cages.

· Diabetic rats will be randomized based on their blood glucose level into six groups of 8 animals each.

· Group G1 and G2 animals will be treated as normal control (without diabetes) and diabetic control respectively.

· Both groups will be administered with normal saline or 0.25% Na- CMC.

· Animals of group G3 will be treated as reference control and administered Metformin at the dose of 150 mg/kg; p.o.

· Similarly, animals of group G4, G5 and G6 will be administered with plant extract at different doses.

· All the treatments will be carried out for a period of 21 or 28 days.

· The body weight of the animals will be recorded every week.

· The fasting blood samples will be collected on day 0 (before treatment) 7, 14, 21 and 28 to determine the glucose level.

· At the end of the experiment, blood will be collected by snip-cut at the tip of the tail under mild anesthesia and serum will be separated by centrifugation at 5000 rpm for 10 min.

· Serum samples will be processed for biochemical estimation.

· Animals will be humanely sacrificed; pancreas will be isolated, weighed and processed for histopathological analysis.

5.0 END POINT PARAMETER(S):

·Clinical observation

· Feed water consumption

· Body Weight (day ‘0’, 7, 14, 21 and 28)

· Blood glucose level (day 0, 7, 14, 21 and 28)

· Urine sugar level (day 0, 7, 14, 21 and 28)

· Glycated Hemoglobin (Hb1A/c)

· Lipid Profile- TC, HDL, LDL, VLDL, TG

· Renal Function Profile- Urea, Creatinine, and Uric acid

· Liver Function Profile - Albumin, Globulin, Total Bilirubin, AST, ALT

· Histopathology of Pancreas tissue

6.0  REFERENCE(S):

6.1 Davis SN, Granner DK. Insulin, oral hypoglycemic agents, pharmacology of the endocrine pancreas. In: Goodman and Gilman’s. The pharmacological basis of therapeutics, 10th ed. New York: McGraw Hill, 2001:1679-1714.

6.2 Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27(5):1047-1053.

6.3 Patel DK, Kumar R, Prasad SK, Sairam K, Hemalatha S. Antidiabetic and in vitro antioxidant potential of Hybanthus enneaspermus (Linn) F. Muell in streptozotocin-induced diabetic rats. Asian Pacific Journal of Tropical Biomedicine, 2011; 1:316-322.

6.4 Onakpa Michael Monday, Asuzu Isaac Uzoma. Histological changes and antidiabetic activities of Icacina trichantha tuber extract in beta-cells of alloxan-induced diabetic rats. Asian Pac J Trop Biomed 2013; 3(8): 628-633.

6.5 Sze Han Ng, Mohd Shazwan Mohd Zain, Fatariah Zakaria, Wan Rosli Wan Ishak, and Wan Amir Nizam Wan Ahmad. Hypoglycemic and Antidiabetic Effect of Pleurotus sajor-caju Aqueous Extract in Normal and Streptozotocin-Induced Diabetic Rats. Biomed Res Int. 2015; 2015: 214918.

6.6 Source Research Needs YouTube Channel: Diabetes-Induced Erectile Dysfunction Video  

                                   END OF DOCUMENT

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