NCT06686069Not yet recruiting
Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Insulin Resistance.
Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Insulin Resistance. A Phase 3, Randomized, Double-blind, Placebo-controlled Explorative Study in Overweight and Obese Patients With Pre-diabetes.
Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- 18 Jan 2025
- Primary completion date
- 18 Nov 2025
- Lead sponsor
- Federico II University
- Diseases
- Obesity
- NCT number
- NCT06686069
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 18 Jan 2025 to the primary completion date, 18 Nov 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Lab values
- 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);
- patients on treatment with insulin or any anti-diabetic drugs or medications known to influence glucose tolerance will also be excluded;
Other
- pregnant or breast-feeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.