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

NCT06686069 | Not Yet Recruiting

• 2 other identifiers: 1808931893
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes; Pre-diabetes; Metabolic Syndrome

Keywords

L-bioarginine

Outcome Measures

Primary Outcomes (1)

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

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

  3 months

Study Arms (2)

placebo, untreated

PLACEBO COMPARATOR

No treatment

Dietary Supplement: bioarginina zero; Dietary Supplement: Placebo

bioarginina zero

ACTIVE COMPARATOR

L-arginine treatment

Dietary Supplement: bioarginina zero; Dietary Supplement: Placebo

Interventions

bioarginina zero DIETARY_SUPPLEMENT

treatment

bioarginina zero; placebo, untreated

Placebo DIETARY_SUPPLEMENT

absence of treatment

bioarginina zero; placebo, untreated

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Insulin Resistance; Hyperinsulinism

Central Study Contacts

barbara maglione, Master degree

CONTACT

3343293357; barbara.maglione@farmadamor.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A and B vials given by physicians to the enrolled patients
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Development

Model Details: Treatment with L-arginine vs placebo

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 13, 2024
• Study Start: January 18, 2025
• Primary Completion: November 18, 2025
• Study Completion: December 30, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share