Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Ins… (NCT06686069) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Insulin Resistance.
42 participantsStarted 2025-01-18
Plain-language summary
The objective of this clinical trial is to explore whether L-arginine supplementation with 3.32g/day may enhance antioxidant defenses in overweight and obese patients with pre-diabetes and metabolic syndrome, possibly providing beta cell function and insulin resistance improvement. The primary efficacy endpoint will be to explore the effects of a short-term L-arginine supplementation on AOPP levels and PAI after three months of treatment, based on the rationale explained above. Secondary, the effects of L-arginine supplementation on lipid peroxidation products and antioxidant defenses will be explored. Tertiary, the effects of L-arginine supplementation on insulin resistance and glucose metabolism parameters will be also evaluated.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* consented male and female patients aged 20-70 years with Body Mass Index (BMI) \>25 kg/m2,
* pre-diabetes (fasting glucose 100-125 mg/dL and HbA1c 5.7-6.5%) or metabolic syndrome, defined according to modified NCEP-ATP III criteria (Grundy SM et al., Circulation, 2005) as the presence of three or more of the following clinical features: blood glucose levels \>100 mg/dL, HDL-cholesterol \<40 mg/dL in males and \<50 mg/dL in females, triglycerides levels \>150 mg/dL, waist circumference \>102 cm in males and \>88 cm in females and hypertension, defined as repeated blood pressure measurements \>130/85 mmHg.
Exclusion Criteria:
* moderate to severe renal impairment (calculated creatinine clearance (CrCl) \<60 mL/min according to the Cockcroft-Gault formula);
* hepatic dysfunction (ALT/AST \>3 x upper limit of normal and total bilirubin \>3 mg/dL);
* hypoalbuminemia (serum albumin \<3 g/dL);
* history of any past or current clinically significant cardiovascular diseases;
* monogenic, secondary and pharmacological causes of diabetes and obesity;
* any other clinical condition/disease that the Principal Investigator believes might confound study outcome;
* patients on treatment with insulin or any anti-diabetic drugs or medications known to influence glucose tolerance will also be excluded;
* pregnant or breast-feeding women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
effects of a short-term L-arginine supplementation on AOPP levels after three months of treatment