Erectile Dysfunction With Diabetes MellitusNCT06220968
Impact of Glycemic Control on Penile Duplex Results
An observational study of Erectile Dysfunction With Diabetes Mellitus, run by Assiut University.
Trial summary
The study aimed at evaluating the impact of glycemic control on the erectile function , penile Doppler, and cavernosal blood NO and glutathione levels among a group of diabetic patients with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men only
- Conditions the study is for
- Erectile Dysfunction With Diabetes Mellitus
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Mar 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Men only
- Adult
Study population: This prospective observational study will include 100 patients attending our andrology outpatient clinic at Assuit University Hospitals, Egypt, complaining of uncontrolled diabetes mellitus (HBA1C more than 8) and secondary ED for more than 6 months, from October 2023 and over a year. Patients will be included in the study after obtaining a written informed consent and ethical committee approval.
Who may be able to join
- Married Male patients diagnosed with erectile dysfunction.
- Age from 30 to 55 years.
- Documented history of DM.
- Regular sexual life with cooperative wife.
Who cannot join
- Patients with congenital anomalies like hypospadius and curvature.
- History of pelvic or spine surgery.
- Single patient.
- . Thyroid disorders.
- Other sexual disorders.
- Primary ED.
- History of Peyronie's disease or priapism.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Glycemic Control on Erectile Function and Penile Doppler in Patients With Erectile Dysfunction
The study aimed at evaluating the impact of glycemic control on the erectile function , penile Doppler, and cavernosal blood NO and glutathione levels among a group of diabetic patients with erectile dysfunction.
Read the detailed description
Erectile dysfunction (ED) is defined as the inability to achieve or maintain a sufficient erection to engage in sexual intercourse.
Although ED is a benign disorder, it affects physical and psychosocial health and has a significant impact on the quality of life of sufferers and their partners and families. Approximately, 5-20% of men have moderate to severe ED.
Risk factors for ED include age, diabetes, hypertension, obesity, lack of exercise, dyslipidemia, smoking, depression, lower urinary tract symptoms, and pelvic surgery, some of which can be modified. In accordance with the International Society of Impotence Research, ED may be classified into three subtypes: organic (that includes iatrogenic, neurogenic, vasculogenic, and hormonal), psychogenic, and mixed ED. Therefore, a thorough investigation ought to be performed by a multidisciplinary team to avoide misdiagnosis.
In the past, psychogenic cause was considered the most important etiological factor of ED; however, currently, organic factors account for 60-90% of this condition. Endocrinopathies can potentially affect erectile function, most notably hypogonadism, hyperthyroidism, hypothyroidism, and diabetes. The patient's history can raise suspicion for such diagnoses; however, there is significant variability in presentation. To aid in the diagnosis, several screening surveys have been suggested and tested, particularly in the case of hypogonadism. Yet, lack of sensitivity and specificity has led to limited utility. Ultimately, endocrinopathies are evaluated and diagnosed with the use of serum hormonal levels.
Penile erection is a haemodynamic event resulting from a complex interaction between the nervous system and cavernosal tissue (smooth muscle and endothelium). Nitric oxide (NO), synthesized from L-arginine by nitric oxide synthase (NOS), was considered to be the major mediator of corporal smooth muscle cell relaxation.
Lipid peroxidation is thought to be an important biological sequence of oxidative cellular damage. Glutathione (GSH), a substrate of glutathione peroxidase defensive mechanism, is an inhibitor of lipid peroxidation. Thus it is a preventive mechanism for oxidative stress.
Diabetes mellitus (DM) has been associated with erectile dysfunction (ED). The generation of reactive oxygen species (oxidative stress) and the reduction of antioxidant defence in diabetes may play an important role in the aetiology of this complication. Hyperglycaemia may increase the generation of free radicals through glucose oxidation, lipid peroxidation, polyol pathway activation, prostanoid synthesis, non-enzymatic protein glycation, and subsequent oxidative degradation of glycated proteins. Furthermore, exposure of endothelial cells to high glucose leads to augmented production of superoxide anion, which may quench NO. The antioxidant defence mechanisms involve both enzymatic and non-enzymatic strategies. Common antioxidants include vitamins A, C, E, GSH and the enzymes superoxide dismutase, catalase, glutathione peroxidase and reductase. GSH is an electron donor and is able to reduce and to scavenge free radicals; in the reduced form GSH is the most important cell antioxidant. Reduced levels of GSH, due both to a hyperglycaemia-induced increase of free radical production and to a decrease of NADPH levels (like in DM), can impair the endothelial cell functions.
Penile Doppler ultrasound (PDU) study is a diagnostic modality useful in elucidating the cause of ED and the magnitude of its severity. PDU also provides a dynamic, quantifiable and reliable method for evaluation of several structural conditions in the penis. It can also help in detecting fibrotic plaques and calcifications characteristic of Peyronie's disease (PD), defects in the tunica albuginea and variable echogenicity in corpora cavernosa in the case of trauma or features of priapism (differentiating between high and low flow), arteriocavernosal fistulas and high-resistance cavernosal arterial flow in addition to anatomic variations in vasculature. Furthermore, it is suggested that DUS is less time consuming and requires less specialized equipment and facilities than does cavernosometry.
However, despite all these advantages and implications of PDU , it still has some precautions to have a valid result such as experienced physician and good circumstances during examination to alleviate stress and anxiety also type of the used vasoactive substances and their dosing regimen and previous treatment used before the penile imaging that can interfere with the accuracy of the test.
As diabetes mellitus is considered one of the main organic causes of Ed pathophysiology, the investigators are conducting this prospective study to evaluate the impact of glycemic control on erectile function and answer the question of whether diabetic control is a prerequisite before requesting penile duplex for diabetic males with ED in order to have a valid imaging result .
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile doppler ultrasound
penile Doppler and measuring cavernosal blood nitric oxide and glutathione levels to compare penile doppler ultrasound brfore and after glycemic control .
Measured: Baseline
Cavernosal blood nitric oxide
Comparing cavernosal blood nitric oxide brfore and after glycemic control
Measured: Baseline
Cavernosal blood glutathione level
Comparing cavernosal blood glutathione levels brfore and after glycemic control
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction With Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelradi Khalaf, Assiut University
- Investigators
- Ahmed Ab Elshibany, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220968
- Sponsor's protocol ID
- Penile duplex
- Status last verified
- Sep 2024
- First submitted
- 19 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycemic Control on Erectile Function and Penile Doppler in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06220968
- Acronym / sponsor ID
- Penile duplex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed at evaluating the impact of glycemic control on the erectile function , penile Doppler, and cavernosal blood NO and glutathione levels among a group of diabetic patients with erectile dysfunction.
Detailed description
Erectile dysfunction (ED) is defined as the inability to achieve or maintain a sufficient erection to engage in sexual intercourse.
Although ED is a benign disorder, it affects physical and psychosocial health and has a significant impact on the quality of life of sufferers and their partners and families. Approximately, 5-20% of men have moderate to severe ED.
Risk factors for ED include age, diabetes, hypertension, obesity, lack of exercise, dyslipidemia, smoking, depression, lower urinary tract symptoms, and pelvic surgery, some of which can be modified. In accordance with the International Society of Impotence Research, ED may be classified into three subtypes: organic (that includes iatrogenic, neurogenic, vasculogenic, and hormonal), psychogenic, and mixed ED. Therefore, a thorough investigation ought to be performed by a multidisciplinary team to avoide misdiagnosis.
In the past, psychogenic cause was considered the most important etiological factor of ED; however, currently, organic factors account for 60-90% of this condition. Endocrinopathies can potentially affect erectile function, most notably hypogonadism, hyperthyroidism, hypothyroidism, and diabetes. The patient's history can raise suspicion for such diagnoses; however, there is significant variability in presentation. To aid in the diagnosis, several screening surveys have been suggested and tested, particularly in the case of hypogonadism. Yet, lack of sensitivity and specificity has led to limited utility. Ultimately, endocrinopathies are evaluated and diagnosed with the use of serum hormonal levels.
Penile erection is a haemodynamic event resulting from a complex interaction between the nervous system and cavernosal tissue (smooth muscle and endothelium). Nitric oxide (NO), synthesized from L-arginine by nitric oxide synthase (NOS), was considered to be the major mediator of corporal smooth muscle cell relaxation.
Lipid peroxidation is thought to be an important biological sequence of oxidative cellular damage. Glutathione (GSH), a substrate of glutathione peroxidase defensive mechanism, is an inhibitor of lipid peroxidation. Thus it is a preventive mechanism for oxidative stress.
Diabetes mellitus (DM) has been associated with erectile dysfunction (ED). The generation of reactive oxygen species (oxidative stress) and the reduction of antioxidant defence in diabetes may play an important role in the aetiology of this complication. Hyperglycaemia may increase the generation of free radicals through glucose oxidation, lipid peroxidation, polyol pathway activation, prostanoid synthesis, non-enzymatic protein glycation, and subsequent oxidative degradation of glycated proteins. Furthermore, exposure of endothelial cells to high glucose leads to augmented production of superoxide anion, which may quench NO. The antioxidant defence mechanisms involve both enzymatic and non-enzymatic strategies. Common antioxidants include vitamins A, C, E, GSH and the enzymes superoxide dismutase, catalase, glutathione peroxidase and reductase. GSH is an electron donor and is able to reduce and to scavenge free radicals; in the reduced form GSH is the most important cell antioxidant. Reduced levels of GSH, due both to a hyperglycaemia-induced increase of free radical production and to a decrease of NADPH levels (like in DM), can impair the endothelial cell functions.
Penile Doppler ultrasound (PDU) study is a diagnostic modality useful in elucidating the cause of ED and the magnitude of its severity. PDU also provides a dynamic, quantifiable and reliable method for evaluation of several structural conditions in the penis. It can also help in detecting fibrotic plaques and calcifications characteristic of Peyronie's disease (PD), defects in the tunica albuginea and variable echogenicity in corpora cavernosa in the case of trauma or features of priapism (differentiating between high and low flow), arteriocavernosal fistulas and high-resistance cavernosal arterial flow in addition to anatomic variations in vasculature. Furthermore, it is suggested that DUS is less time consuming and requires less specialized equipment and facilities than does cavernosometry.
However, despite all these advantages and implications of PDU , it still has some precautions to have a valid result such as experienced physician and good circumstances during examination to alleviate stress and anxiety also type of the used vasoactive substances and their dosing regimen and previous treatment used before the penile imaging that can interfere with the accuracy of the test.
As diabetes mellitus is considered one of the main organic causes of Ed pathophysiology, the investigators are conducting this prospective study to evaluate the impact of glycemic control on erectile function and answer the question of whether diabetic control is a prerequisite before requesting penile duplex for diabetic males with ED in order to have a valid imaging result .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- This prospective observational study will include 100 patients attending our andrology outpatient clinic at Assuit University Hospitals, Egypt, complaining of uncontrolled diabetes mellitus (HBA1C more than 8) and secondary ED for more than 6 months, from October 2023 and over a year. Patients will be included in the study after obtaining a written informed consent and ethical committee approval.
Key inclusion criteria (4 listed)
- Married Male patients diagnosed with erectile dysfunction.
- Age from 30 to 55 years.
- Documented history of DM.
- Regular sexual life with cooperative wife.
Key exclusion criteria (7 listed)
- Patients with congenital anomalies like hypospadius and curvature.
- History of pelvic or spine surgery.
- Single patient.
- . Thyroid disorders.
- Other sexual disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Penile doppler ultrasound
Time frame: Baseline
penile Doppler and measuring cavernosal blood nitric oxide and glutathione levels to compare penile doppler ultrasound brfore and after glycemic control .
Cavernosal blood nitric oxide
Time frame: Baseline
Comparing cavernosal blood nitric oxide brfore and after glycemic control
Cavernosal blood glutathione level
Time frame: Baseline
Comparing cavernosal blood glutathione levels brfore and after glycemic control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Erectile Dysfunction With Diabetes Mellitus
RecruitingPhase 2/3
Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction
Erectile Dysfunction With Diabetes Mellitus
Recruiting
Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?
Diabetes Mellitus, Erectile Dysfunction
Not yet recruitingPhase 2
Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction
Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Enrolling by invitation
Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)
Erectile Dysfunction Due to General Medical Condition, Erectile Dysfunction Following Radical Prostatectomy
RecruitingObservational study
Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)
Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Ab Elshibany principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction With Diabetes Mellitus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ab Khalaf (01220570189, MahmoudFakir152997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile doppler ultrasound (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.