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The Effect of L-Arginine Supplementation on Hypogonadism in Patients witht Diabetes Type 2.

Phase 3
Recruiting
Conditions
Diabetes Type 2.
Diabetes mellitus due to underlying condition
Registration Number
IRCT20220112053700N1
Lead Sponsor
Arak University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
50
Inclusion Criteria

Male Gender
Erectile Dysfunction (ED) for at Least 3 Months
Having Type 2 Diabetes for at Least a Year
Total Testosterone Levels Less than 8 nanomol /Liter or Serum Testosterone in the Range of 8 to 11 nanomol /Liter and Free Testosterone Levels Less than 220 picomoles /Liter
Age 40 to 60 Years
HBA1C Between 5.5 and 7 (Low and Moderate Risk Diabetes)
Do not Take Exogenous Anabolic Steroids

Exclusion Criteria

Patients with Erectile Dysfunction (ED) of known Psychological Origin
Patients with Prostate Cancer or Benign Prostatic Hyperplasia
Patients with a History of Sleep Apnea
Patients with Spinal Cord Injury
Patients with known and treated Cardiopulmonary Injury
Patients with Hyperthyroidism or Hypothyroidism
Patients with known Liver Failure
Patients with known Renal Failure
Patients with a History of Seizures
Patients with known Microvascular Complications of Diabetes (Retinopathy, Neuropathy, Nephropathy
Taking Anti-Libido Drugs
Taking Antipsychotic or Mood Stabilizing or Antidepressant Medications

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Individuals with the International Index of Erectile Function-5 Questionnaire Score of Less than 21. Timepoint: Filling in the Questionnaire at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: The International Index of Erectile Function-5.;Free and Total Testosterone Serum Levels. Timepoint: Measurement of Free and Total Testosterone Serum Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: Laboratory Kit by ELISA Method.
Secondary Outcome Measures
NameTimeMethod
Fasting Blood Suger. Timepoint: Measurement of Fasting Blood Sugar Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: Laboratory Kit by ELISA Method.;Hemoglobin A1C. Timepoint: Measurement of Hemoglobin A1C Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: Laboratory Kit by ELISA Method.
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