Evaluation of the effect of Atorvastatin administration time in the morning and evening on lipid profile in patients with type 2 diabetes

Evaluation of the effect of Atorvastatin administration time in the morning and evening on lipid profile in patients with type 2 diabetes referred to Ayatollah Rouhani Hospital

This study is a clinical trial with a control group, with parallel groups, blinded assessor, randomized on 76 patients who were divided into two groups(atorvastatin prescription in the morning and atorvastatin prescription in the evening) are divided. Randomization by method permuted block design will be done using the website www.sealedenvelope.com.

All patients with type 2 diabetes referred to endocrine clinic of Ayatollah Rouhani Hospital who have an indication for receiving statin. Demographic information of patients will be collected in a checklist. After obtaining informed consent, the samples will be divided into two groups (atorvastatin administration in the morning and atorvastatin administration in the evening).Due to the nature of the treatment, in which the time of use is different, it is not possible to blind the patients.The person who is blind during the study is the assessor. After 12 hours of fasting, 5 cc of volunteers' blood is taken in the laboratory of Ayatollah Rouhani Hospital and the middle of lipids is measured by Pars Azmoon kit. After 4 weeks, lipid profiles will be measured again in the same laboratory and with the same measurement kit. Blood lipid levels will be recorded in the checklist.

Inclusion criteria : any diabetic patient over the age of 40 years Exclusion criteria : People with renal failure Cancer patients People who have used lipid-lowering drugs before

The first group will be prescribed atorvastatin in the morning and the second group will be prescribed atorvastatin in the evening.

Comparison of change in blood lipid levels ; complications in both groups

Randomization will be done by permuted block design. The size of the blocks is 4.In each block equal number of intervention (Administer medicine in the morning) and control (Administer medicine in the evening) are placed. Sequence production for randomization will be done by a statistician and using the www.sealedenvelope.com website. Envelopes of the same shape will be prepared and in closed envelopes, the time of receiving the medicine (morning / evening) is specified, the order of these envelopes will be determined using random blocks and through the www.sealedenvelope.com website. To hide the treatment process, envelopes of the same shape are prepared according to the number of people to be studied. Three-digit codes are written on the envelopes. After each person enters the study, to allocate his treatment time, one of these envelopes (in a specific order) is given to that person by the secretary and the code on the envelope is recorded on the patient's file. At the end of the study, the codes will be reopened.

Blindness Due to the nature of treatment in which the time of use is different (For some patients it will be prescribed in the morning and for others in the evening) blinding patients is not possible. Due to the process and method of randomization ,The person who will be blind during the study is the assessor , the assessor does not know the time of drug administration.. Therefore, this study is out come assessor blind.