EVALUATION OF ANTI-DIABETIC POTENTIAL OF TEST FORMULATION(S) IN NICOTINAMIDE-STREPTOZOTOCIN INDUCED TYPE-II DIABETES IN EXPERIMENTAL RATS

 

EVALUATION OF ANTI-DIABETIC POTENTIAL OF TEST FORMULATION(S) IN NICOTINAMIDE-STREPTOZOTOCIN INDUCED TYPE-II DIABETES IN EXPERIMENTAL RATS

1.0 INTRODUCTION:

Diabetes is characterized by increased blood glucose (BG), metabolic disturbances, and alteration in insulin secretion. This insulin-deficient action is due to shortage of insulin secretion (type 1 diabetes) and/or decline in cell response toward insulin (type 2 diabetes). Symptoms of hyperglycemia include polyuria, polydipsia, polyphagia, weight loss, ketonemia, and ketonuria. Thus diabetes causes cardiovascular disease, retinopathy, neuropathy and other long-term complications in uncontrolled conditions.

2.0 TEST SYSTEM DETAILS:

Species             : Rattus norvegicus (Rat)

Strain                : Wistar or Sprague Dawley

Age                   : 8-10 weeks

Body Wight        : 150-200 g

Sex                   : Male/Female

No. of animals    : 08 /Group

Total Animals     : 56+10 Extra= 66

3.0  ALLOCATION OF GROUPS:

Groups	Treatment	Dose; ROA	No. of Animals
G1	Normal Control	Normal saline or 0.25% Na-CMC	08
G2	Diabetic Control	Normal saline or 0.25% Na-CMC	08
G3	Reference Drug- Glyburide	10 mpk; p.o.	08
G4	Test Formulation-1	X mpk; p.o.	08
G5	Test Formulation -1	XX mpk; p.o.	08
G6	Test Formulation -2	X mpk; p.o.	08
G7	Test Formulation -2	XX mpk; p.o.	08

 

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

 

4.0 METHOD:

·   Diabetes will be induced by streptozotocin (60 mg/kg; i.p), 15 min after the intraperitoneal administration of nicotinamide (120 mg/kg; i.p).

·     After 7 days rats showing fasting blood glucose between 180 and 220 mg/dL will be considered diabetic and include in the study. 

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

·       Diabetic animals will be randomized based on the blood glucose level into seven groups of 08 animals each.

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

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

·    Animals of group G3 will be treated as reference control and administered Glyburide at the dose of 10 mg/kg; p.o.

·  Similarly, animals of group G4 to G7 will be administered with test

formulation(s) at different doses.

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

·       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 Yogendra Nayak, Hillemane, Vijay, B. S. Jayashree  and M. K. Unnikrishnan. Antidiabetic Activity of Benzopyrone Analogues in Nicotinamide-Streptozotocin Induced Type 2 Diabetes in Rats. Scientific World Journal.  2014; 2014: 854267.

6.2 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.

6.3 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.

6.4 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.

                                        END OF DOCUMENT

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