Evaluation of the Effects of Inositol Supplementation on inflammatory status, oxidative stress, fatigue, and insulin resistance and lipid profile in type 2 diabetic patients with chronic kidney disease: Double-blind randomized clinical trial (RCT)

To evaluate the effect of inositol supplementation on inflammation, oxidative stress, fatigue, insulin resistance, and lipid profile in patients with type 2 diabetes and chronic kidney disease.

A randomized, double-blind, placebo-controlled, parallel trial will be conducted on 48 patients with type 2 diabetes and CKD stages 3–4. After a two-week run-in, participants will be allocated to inositol and placebo groups using stratified block randomization by age and sex (blocks of four). The intervention lasts 8 weeks.

This study will be conducted in Shariati and Shohadaye Tajrish kidney clinics, Tehran. After convenience sampling and consent, participants will complete two-week run-in and baseline assessment, then be randomly allocated to intervention/control groups to receive inositol or placebo for 8 weeks. Participants, investigators, and outcome assessors will be blinded; supplements will be similar and coded.

Patients with type 2 diabetes and CKD stage 3–4 before dialysis, aged 20–60 years, BMI 20–30 kg/m², and willing to participate will be included. Individuals with glucocorticoid, antibiotic, fluvoxamine, NSAID, or warfarin use, smoking, recent hospitalization, autoimmune/thyroid diseases, malignancies, antioxidant use, pregnancy, planned pregnancy, or breastfeeding will be excluded.

After run-in, participants will be randomly allocated to intervention and control groups. The inositol group will receive 1600 mg/day (two 800 mg supplements), and the control group placebo. Both groups will maintain dietary intake, physical activity, and medication regimen. The intervention lasts 8 weeks.

Inflammatory markers (IL-6 and TNF-α); oxidative stress (MDA and TAC); fatigue; insulin resistance (HOMA-IR, QUICKI, and TyG); lipid profile (TG, TC, LDL, and HDL)

After completion of the run-in period and baseline assessments, eligible participants will be randomly allocated to the intervention and control groups. Stratified block randomization will be used for allocation. The unit of randomization will be the individual participant. Participants will first be stratified according to sex (male/female) and age, and then within each stratum, they will be randomly assigned to the intervention group (inositol supplementation) or control group (placebo) using blocks of four. The random allocation sequence will be generated using statistical software. Group allocation will remain concealed from investigators and participants until the initiation of the intervention.

This study will be conducted as a double-blind clinical trial. Participants, investigators, care providers, and outcome assessors will be blinded to the group allocation. The inositol supplement and placebo will be identical in appearance, packaging, and administration method. To maintain blinding, the supplements and placebo will be coded by an individual who is not involved in participant assessment or data analysis. Participants will not be informed whether they receive inositol supplementation or placebo during the study period. Individuals responsible for intervention delivery, data collection, clinical and laboratory assessments, and outcome evaluation will remain unaware of participants’ group assignments. The allocation codes will remain concealed from investigators and data analysts until completion of data collection and final statistical analysis. The codes will be revealed after completion of the final analysis.

Due to the confidentiality of participants’ clinical and personal information and adherence to ethical research principles, individual participant data will not be shared.