The effect of Grape seed extract on Fasting blood glucose, Lipid profile and Blood pressure in patients with type 2 diabetes mellitus; A randomized double blind clinical trial.

Determination of the effect of Grape seed on fasting blood glucose level, lipid profile and blood pressure in patients with type 2 diabetes mellitus

Clinical trial with control group, with parallel groups, double-blind, randomization, phase 3 on 80 patients.

Samples of patients with type 2 diabetes who are being treated with oral hypoglycemic drugs and referred to the diabetes clinic of Golestan hospital in Ahvaz on an outpatient basis They will be selected. All patients are asked to continue their previous medications to control their blood sugar, fat, and blood pressure during treatment, according to their doctor, and should not change their dose during the study. Patients are divided into two groups using a randomized list (40 patients in each group). Group A in addition to antidiabetic drugs, Grape seed herbal pills and group B in addition to antidiabetic drugs will be given placebo tablets (containing starch).

Age 25_80 years, HBA1C 7% _8. 5%, Fasting blood sugar between 126-200 mg / dL, The diagnosis of diabetes is less than 10 years, Patients should use only oral hypoglycemic drugs, BMI <35 Exclusion criteria Pregnancy-breastfeeding, Insulin therapy, Significant renal and hepatic impairment (overt renal failure if CLCr <30 and severe hepatic impairment if ALT or AST greater than 100)

The intervention group consumed two grape seed tablets daily and the control group consumed two placebo tablets (containing starch) daily for 30 days.

Fasting blood sugar, TG, HDL, LDL, Chol, systolic blood pressure and diastolic blood pressure

In this study, we will use the randomization method of permutation blocks. In this two-group clinical trial, the size of blocks 4, 6 and 8 is considered (in this method, the number of people assigned to each group in the blocks is equal). For concealment, we use concealment allocation, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque, sealed, numbered sequentially sealed non-transparent envelopes (envelopes opaque, sealed, numbered sequentially) in which in this method each random sequence is recorded on a card and the cards are placed in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. Randomization list using PLAN procedure in the software SAS is generated.

In this study, patients do not know the type of drug (placebo or herbal pill ..). The patient evaluator is also not aware of the type of treatment assigned to patients so that patients can be evaluated without any bias. Therefore, this study will be performed based on the two-blind method.