Study the effect of oral supplements “zinc and magnesium” on the control of Hemoglobin A1c in type II diabetic patients referred to Qom Shahid Beheshti hospital 2017-2018

Determination of the efficacy of supplemental zinc and magnesium alone and co-administration on the hemoglobin A1c control in type II diabetic patients

Factorial clinical trial, with control group, triple-blind, randomized

First, patients with type II diabetes who are referred to the internal or endocrinology clinic of Shahid Beheshti Hospital are identified. Individuals are randomly divided into four groups. Individuals, in direct people and those who analyze the data, are unaware of the allocation of patients to different groups. The necessary tests performed through the laboratory of Shahid Beheshti Hospital and the rate of progression of diabetic neuropathy by The Michigan Neuropathy Instrument (MNSI) and Diagnostic Tool are used to check the progression of diabetic neuropathy every three months. Also, demographic information is completed by questionnaires.

Inclusion criteria: - Diabetic Type 2 Proven by Metabolic Indicators (FBS and 2HBP) - At least 3 years of diabetes history - aged over 20 Exit criteria: - Age over 60 - People with a history of myocardial infarction - People with hypermagnesemia - People with hyperzincemia - People with diabetic nephropathy - Insulin Consumers

Intervention group1: Patient who receive oral zinc in the amount of 220 mg zinc sulfate, three days a week for six months. Intervention group 2: Patient receive magnesium oxide 250 mg three days a week for six months. Intervention group 3: Patient who receive magnesium oxide 250 mg three days a week and oral zinc as zinc sulfate at 220 mg three days a week for six months. Control group: The control group, which includes Patient who receives placebo only for six months in addition to medication

Percentage of hemoglobin A1c in people with type 2 diabetes

Random allocation method is based on blocking. Four blocks are used. The list of 24 blocks is written and randomly a number is selected and the sampling is continued based on it. ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA, CDAB, CDBA, DABC, DACB, DBCA, DBAC, DCAB, DCBA

After dividing people into four different groups, patients are referred to the clerk and they train their medication and the correct way of taking them. Medications are pre-prepared and packaged out and packed in new ones as they are inserted on new packets of English letters, and the person who does not have direct intervention knows their meaning. Drug and placebo formulations of the same color The color and appearance of zinc, magnesium, and placebo tablets are identical. Patients refer to the doctor after the assignment of the code in the group and the physician is unaware of their allocation to the different groups and only the secretary delivers the package of the patient package to the patient.

All data can be shared after unidentifiable patients.

Start the access period one year after the publishing results

Researchers working in academic centers and pharmaceutical companies

The use of data obtained for the purpose of directing and completing research projects is permissible.

To receive the data, send your request to Narges Kalhor at narges.kalhor1997@gmail.com.

The request will be reviewed by the clinical trial responsible and the data will be sent to him after verifying the accuracy of the information received from the applicant.