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The effects of L-arginine supplementation in diabetic hemodialysis patients

The effects of L-arginine supplementation on anthropometric indices, lipid profiles, glycemic control, insulin resistance, oxidative stress and fatigue status in diabetic hemodialysis patients: A Randomized, Double Blind, Placebo Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170202032367N12
Enrollment
52
Registered
2025-12-18
Start date
2026-04-09
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease. Chronic kidney disease, stage 5

Interventions

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 30 and 60 years Undergoing regular hemodialysis (for at least the past 6 months, three sessions per week) Body mass index (BMI) greater than 18.5 and less than 30 kg/m² No hospitalization during the past 3 months Willingness to participate and cooperate in the study

Exclusion criteria

Exclusion criteria: Blood pressure higher than 160/100 mmHg Blood pressure lower than 60/100 mmHg Receiving enteral or parenteral nutritional support Use of glucocorticoids, antibiotics, Fluvoxamine, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, or nitroglycerin Smoking History of any autoimmune diseases, thyroid disorders, malignancies, asthma, herpes, or myocardial infarction (MI) Use of antioxidant supplements within the past 3 months History of coronary artery bypass grafting (CABG) less than 12 months prior to study enrollment Kidney transplantation less than 6 months prior to study enrollment Hospitalization within the past 3 months Pregnancy, intention to become pregnant within the next 6 months, or breastfeeding

Design outcomes

Primary

MeasureTime frame
Serum levels of Glycemic control (FBS, HbA1c, and fasting insulin). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Diagnostic kits.;Insulin resistance indices (HOMA-IR, HOMA-beta, TyG, QUICKI). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Calculated using the relevant formula.

Secondary

MeasureTime frame
Serum levels of lipid parameters (T.G, T.C, LDL, HDL). Timepoint: Before the intervention and 12 weeks later. Method of measurement: spectrophotometry method.;Serum levels of oxidative stress markers (TAC, MDA). Timepoint: Before the intervention and 12 weeks later. Method of measurement: spectrophotometry method.;Fatigue status. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Completion of the Fatigue Assessment Scale (FAS) questionnaire.;Systolic and diastolic blood pressure. Timepoint: Before the intervention and 12 weeks later. Method of measurement: Sphygmomanometer and calibrated stethoscope.;Anthropometric indices (body weight, body mass index, skeletal muscle mass index, fat mass, extracellular water to total body water ratio, and phase angle). Timepoint: Before the intervention and 12 weeks later. Method of measurement: Anea BIA 1204 body composition analysis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Imani

Tehran University of Medical Sciences

h_imani@sina.tums.ac.ir+9821889900285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026