The effect of chromium administration on mean serum levels of HbA1C, FBS and 2hpp in diabetic patients: A double-blind randomized controlled clinical trial

Determining the effect of chromium drug administration on the mean serum levels of HbA1C, FBS and 2hpp in diabetic patients

Clinical trial with an intervention group, with a parallel group; One side blind, random

This study is conducted in Waliasr Hospital, Birjand, South Khorasan Province. 50 patients are randomly divided into two intervention groups, one or two (A-B). Questions related to the effectiveness of the intervention before and 3 months after the treatment will be collected and evaluated by the blood sample operator.

Our study population will be diabetic patients living in the city of Birjand referring to the diabetes clinic and the specialized clinic of Valiasr Hospital in Birjand in 2023. Inclusion criteria 1. Age over 40 years 2. Patients with type 2 diabetes 3. Having diabetes for at least 6 months 4. Patients treated with oral medicine 5. Glycosylated hemoglobin below 9 Exclusion criteria 1. Patients consuming minerals, vitamins or antioxidants or medicinal plants 2. Pregnant or lactating women 3. Disease with heart failure 4. Having another chronic disease 5. Thyroid problems, either hypo or hyperthyroid 6. Treatment of hyperlipidemia 7. Having complications of diabetes including retinopathy, neuropathy and nephropathy 8. Receiving insulin 9. Patients with kidney and liver failure 10. Patients undergoing treatment for gastrointestinal diseases

The intervention groups are as follows: intervention group A received chromium picolinate tablets 200 mg twice a day (after meals and on a full stomach) for 3 months, and in control group B, patients took their routine diabetes medications. And 3 months later they refer for evaluation.

Fasting blood sugar (FBS)؛ Glycosylated hemoglobin (HbA1C)؛ Blood sugar 2 hours after eating (2hhp)

The placement of people in each group will be simple random and in a block method, in one of the two groups A (chromium picolinate tablets 200 mg twice a day after meals and with a full stomach for 3 months), the intervention B (take their routine diabetes medications and will be placed for 3 months). In this way, first, various blocks of four (AABB, BBAA, ABAB, BABA, ABBA and BABA) are created on different cards. One of these blocks will be randomly selected using the lottery method and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well. This will be done by the secretary.

Outcome evaluator: The study leader (3rd year internal medicine assistant) and the laboratory expert, without knowing the type of drug received by the patients, takes the necessary samples and sends them to the laboratory for examination.