Analyzing the effect of oral magnesium on (NDS)Neuropathy Disability Score of peripheral neuropathy in type 2 diabetes patients among subjects of Loghman Hakim Hospital clinic in Tehran

Investigating the effect of oral magnesium on Neuropathy Disability Score in patients with peripheral polyneuropathy of type 2 diabetes

Clinical trial with control group, single blind, randomized, phase 3 is conducted on 60 patients. By choosing a confidence level of 95%, a power of 80% for the two-domain test and an effect size of 0.8 and using G*power 3.1.9.2, the number of samples in each group 26 people were calculated, and considering the possibility of dropout, 30 people are expected in each group. Creating a random sequence of Random Sequence Generation will be done in the form of simple randomization and through the preparation and shuffling of cards.

After obtaining informed consent, people referring to Loghman Hakim Hospital are randomly assigned to control or intervention group. patients are treated with magnesium or a placebo. After 2 months, the symptoms related to peripheral neuropathy will be compared with the time of the initial visit, and the effect of the intervention will be determined.

Inclusion criteria: men and women between the ages of 20 and 85 years old - type 2 diabetes- symptoms of distal neuropathy. Exclusion criteria: other neuropathies, neuromuscular diseases, magnesium level > 2.1, magnesium consumption in the last 3 months, persistent diarrhea and vomiting, diuretic use, thyroid problems or levothyroxine use, chronic kidney disease, use of antidepressants or anticonvulsants or analgesics, pregnancy and breastfeeding, malignancy, amputation or active diabetic foot ulcer.

The intervention group is treated with 300 mg of oral magnesium and the control group is treated with placebo daily for 2 months.

Vibration and temperature sensation, pin-prick test, knee reflex and Neuropathy Disability Score: both in the first visit and in the second visit.

The steps of random assignment of patients to two experimental and control groups will be as follows: 1- Creating a random sequence of Random Sequence Generation will be done in the form of simple randomization and through the preparation and shuffling of cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next groups. Then, by removing them, a card is taken out and its assignment is registered, and that card is returned to the other cards. Then the cards are dealt again and another card is drawn. This process will continue until reaching a random sequence according to the sample size. 2- Random allocation concealment will be done by placing the aforementioned cards inside Sequentially Numbered Sealed Opaque Envelopes (SNOSE). 3- People from the research team who are responsible for the above steps will not enter the other steps of the research, especially the examination of people in terms of the dependent variable.

The patients are unaware of the allocation of the study groups and receive the intervention (drug or placebo).

All variables and information about participants can be shared after de-identifying people

َAt the time of publication

All treatment staff, researchers and people who intend to verify the data will be able to access the data

If the source is mentioned, the data will be made available to the requesters

Refer to the organizers of the plan or to Loghman Hakim Hospital in Tehran

The request is made by email or phone and the information will be sent in the form of e-mail