Objective:
The main aim of this study is to determine the effect of oxymel caper product on metabolic syndrom diagnostic criteria in patients with diabetes type II.
Design:
This study is a triple blind randomized clinical trial on patients with aged 65-30 years and with type 2 diabetes who despite reciewing full dose of oral medication according to ADA guideline, still do not control their diabetes and insulin injections refused and their metabolic syndrome has been approved based on diagnostic criteria of NCEP: ATPIII.
Setting and conduct:
The total number of patients is 42 persons who were randomly divided to three groups (two intervention and one control groups). In all groups including the control group, in addition to conventional therapies (anti-diabetic drugs), patients are received simple sugar syrup regarding to their diabetes and the first intervention group is received simple oxymel and the second control group is received caper oxymel as much as the first interventional group.
Participants including major eligibility criteria:
patients are included with aged 65-30 years and with type 2 diabetes who despite reciewing full dose of oral medication according to ADA guideline, still do not control their diabetes and insulin injections refused and their metabolic syndrome has been approved based on diagnostic criteria of NCEP: ATPIII
patients are excluded with Dissatisfaction with continuing participation؛ Necessity of any new therapeutic intervension during the study based on endocrinologist؛ Breast feeding and lactation؛ Complications such as increasing blood presure, chest pain, fatigue during treatment؛ Renal problem with increasing creatinine and decreasing GFR less than 60؛ Any systematic disease which influence on trend of disease such as cardiac diseases, liver problems and malignancies؛Acute or sever complications of diabete such as DKA, hyperosmolar coma and sever hypoglycemia in recent 3 months؛ The critical illness which leads to hospitalisation in recent 3 months؛ Taking hyperglycemic agent such as immunosupressive and antileptic.
Interventions:
Intervention group1: Caper oxymel including 2000 mg hydroalcoholic extraction of capparis spinosa in oxymel 30 cc per day orally in 2-3 divided doses for 3 month.
Intervention group2: Simple suger oxymel 30 cc per day orally in 2-3 divided doses for 3 month.
Control group: Dextrose syroup (65%), 30 cc per day, orally in 2-3 divided doses for 3 month.
main outcome measures (variables):
During the study period (3 months), diagnostic criteria for metabolic syndrome including waist circumference, FBS, blood pressure and lipid profile as measurable outcomes of the study were determined at the beginning and end of the intervention. Moreover, in order to evaluate the effects or possible side effects of the treatment, other tests including SGPT, SGOT, ALP and creatinine were performed at Before, one month, two month and at the end of the intervention.