Clinical trial

Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Insulin Resistance.

Opening soon · Not applicable · 0 countries · Registry ID NCT06686069

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 90 Years

SexAll

Healthy volunteersAccepted

ConditionDiabetes, Pre-diabetes, Metabolic Syndrome

Full registry criteria

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.

Treatments and study arms

bioarginina zero

Dietary Supplement

treatment

Placebo

Dietary Supplement

absence of treatment

Primary outcomes

effects of a short-term L-arginine supplementation on AOPP levels after three months of treatment3 months

effects of a short-term L-arginine supplementation on AOPP levels and PAI after three months of treatment

Study locations

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No public site location was included in this record. Check the original registry for updates.