Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000433303
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
24/03/2017
Date last updated
8/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
What are diagnosis of the urologists for the causes of erectile dysfunction in patients with nonalcoholic fatty liver disease? An observational study.
Scientific title
What are the clinical causes of erectile dysfunction in patients with nonalcoholic fatty liver disease? A prospective observational study.
Secondary ID [1] 291139 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic fatty liver disease 301981 0
Erectile dysfunction 301982 0
Condition category
Condition code
Oral and Gastrointestinal 301625 301625 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 301626 301626 0 0
Other metabolic disorders
Renal and Urogenital 301744 301744 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
Each patient with nonalcoholic fatty liver disease who is diagnosed erectile dysfunction (using the questionnaire IIEF-5 form) will be consultated to urology (andrology) department for further evaluation. The final opinion and diagnosis of the urology department will be collected for the primary outcome of this study. We plan to passively follow each patient for this purpose. and a maximum of 3 months of observation duration wiil be provided for each participant.
Intervention code [1] 297118 0
Not applicable
Comparator / control treatment
No control group exists
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301023 0
To define the causes of erectile dysfunction among nonalcoholic fatty liver disease. The presence of erectile dysfunction will be diagnosed using a questinnaire called "IIEF-International Index of Erectile Function-5" which is validated in Turkish population.
Timepoint [1] 301023 0
3 months following the andrology clinic consultation
Secondary outcome [1] 331488 0
Relationship between smoking and diagnosed cause of erectile dysfunction. Smoking status will be determined by participant's self-report..de
Timepoint [1] 331488 0
Baseline
Secondary outcome [2] 331829 0
Relationship between age and diagnosed cause of erectile dysfunction. Presence of any correlation between the increased age and the severity of erectile dysfunction scores using IIEF-5 questionnaire will be assessed with spearman's correlation test statistically.
Timepoint [2] 331829 0
Baseline
Secondary outcome [3] 331830 0
Relationship between the components of metabolic syndrome (obesity, hypertension, insulin resistance dyslipidemia) and erectile dysfunction. Body mass index (using height and weight) and waist circumference, blood pressure will be measured by the physician in the baseline visit. Other lab investigations of insulin resistance and lipid profile will be reviewed from the hospital medical records obtained in the past 6 months of the baseline visit. The numeric relationship between the erectile dysfunction scores and the above parameters of metabolic syndrome will be assessed using the statistical test of spearman's correlation test.
Timepoint [3] 331830 0
Baseline

Eligibility
Key inclusion criteria
The male patients who received NASH diagnosis and who accepts to fill the IIEF questionnaire. The diagnosis may be an old diagnosis or a new diagnosis. Diagnosis may be made by histolgically with a liver biopsy or andominal ultrasonography.
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
-Other causes of liver disease that are viral hepatitis, alcoholic liver disease, autoimmune hepatitis, toxic hepatitis, wilson's disease, hemachromatosis.
-Patiients who already have a diaognosis of infertility or erectileddysfunction or who are receiving therapy for it

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2017
Date of last participant enrolment
Anticipated
5/02/2019
Actual
Date of last data collection
Anticipated
5/08/2019
Actual
Sample size
Target
100
Accrual to date
80
Final
Recruitment outside Australia
Country [1] 8647 0
Turkey
State/province [1] 8647 0
Istanbul

Funding & Sponsors
Funding source category [1] 295576 0
Self funded/Unfunded
Name [1] 295576 0
Country [1] 295576 0
Primary sponsor type
Individual
Name
Deniz DUMAN
Address
Marmara University, School of Medicine, Subdivision of Gastroenterology,
Basibuyuk Mah, Maltepe Basibuyuk Yolu Sok. 9/1, 34854 Maltepe/Istanbul
Country
Turkey
Secondary sponsor category [1] 294510 0
None
Name [1] 294510 0
Address [1] 294510 0
Country [1] 294510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296898 0
Marmara University School of Medicine, Clinical Trials Ethics Committee
Ethics committee address [1] 296898 0
Basibuyuk Mah, Maltepe Basibuyuk Yolu Sok. 9/1, 34854 Maltepe/Istanbul
Ethics committee country [1] 296898 0
Turkey
Date submitted for ethics approval [1] 296898 0
17/10/2016
Approval date [1] 296898 0
02/12/2016
Ethics approval number [1] 296898 0
09.2016.593

Summary
Brief summary
We have shown that nonalcoholic fatty liver disease (NAFLD) has associated with erectile dysfunction (ED) in our previous study. The clinical causes of ED, however, are not known. We plan to recruite a new set of NAFLD patients with ED and will advice them to refer to andrology outpatient clinic. Our aim is to simply collect the outcomes of those patients from andrology clinic and investigate the correlation of those outcomes with clinical confounding variables such as age, cigarette smoking, history of hypertension, insulin resistance, dyslipidemia, obesity, drugs used.. Therefore the aim of this study is to identify the causes of ED among the patients with ED.
Trial website
No website is available.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72362 0
Prof Deniz Duman
Address 72362 0
Marmara University School of Medicine, Department of internal Medicine, Division of Gastroenterology, Basibuyuk Mah, Maltepe Basibuyuk Yolu Sok. 9/1, 34854 Maltepe/Istanbul/TURKEY
Country 72362 0
Turkey
Phone 72362 0
+902166254684
Fax 72362 0
Email 72362 0
[email protected]
Contact person for public queries
Name 72363 0
Prof Deniz Duman
Address 72363 0
Marmara University School of Medicine, Department of internal Medicine, Division of Gastroenterology, Basibuyuk Mah, Maltepe Basibuyuk Yolu Sok. 9/1, 34854 Maltepe/Istanbul/TURKEY
Country 72363 0
Turkey
Phone 72363 0
+902166254684
Fax 72363 0
Email 72363 0
[email protected]
Contact person for scientific queries
Name 72364 0
Prof Deniz Duman
Address 72364 0
Marmara University School of Medicine, Department of internal Medicine, Division of Gastroenterology, Basibuyuk Mah, Maltepe Basibuyuk Yolu Sok. 9/1, 34854 Maltepe/Istanbul/TURKEY
Country 72364 0
Turkey
Phone 72364 0
+902166254684
Fax 72364 0
Email 72364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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