EVALUATION OF ANTI-DIABETIC
POTENTIAL OF TEST FORMULATION(S) IN HIGH-FAT DIET/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 a shortage of insulin secretion (type 1
diabetes) and/or a 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 (HFD+veh) |
08 |
|
G3 |
Reference
Drug- Glibenclamide |
10 mpk;
p.o. (HFD+STZ) |
08 |
|
G4 |
Test Formulation-1 |
X mpk;
p.o. (HFD+STZ) |
08 |
|
G5 |
Test Formulation -1 |
XX mpk;
p.o. (HFD+STZ) |
08 |
|
G6 |
Test Formulation-2 |
X mpk;
p.o. (HFD+STZ) |
08 |
|
G7 |
Test Formulation -2 |
XX mpk;
p.o. (HFD+STZ) |
08 |
*The doses and ROA (Routes of administration)
will be decided based on the type of reference drug
4.0 METHOD:
·
Type II diabetes will be
induced by high fat diet (HFD) and low-dose of streptozotocin (STZ) treatment.
· After acclimatization period,
normal rats will be maintained on normal pellet diet while remaining will given
high fat diet for 3 weeks to induce obesity.
·
After 3 weeks, the overnight
fasted rats will be treated by streptozotocin at a dose of 30 mpk; i.p.
·
After 10 days of STZ
injection, fasting blood glucose ~200 mg/dL will be considered diabetic and
include in the study.
·
The diabetic animals will be
allowed free access to water, HFD (till the end of study) 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 8 animals
each.
·
Group G1 and G2 animals will
be treated as normal control (without diabetes) and diabetic control
respectively.
·
Groups G1 and G2 will be
administered with normal saline or 0.25% Na- CMC respectively.
·
Animals of Group G3 will be
treated as reference control and administered Glibenclamide 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 (HbA/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):
6.1Yogendra 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
6.5 Effect of Pleurotus sajor-cajun 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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