Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001217897
Ethics application status
Approved
Date submitted
15/11/2012
Date registered
19/11/2012
Date last updated
19/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Erectile dysfunction in male patients with fatty liver disease
Scientific title
Erectile dysfunction in male patients with Non Alcoholic Steatohepatitis
Secondary ID [1] 281543 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Alcoholic Steatohepatitis 287808 0
Erectile dysfunction 287827 0
Metabolic Syndrome 287828 0
Condition category
Condition code
Oral and Gastrointestinal 288159 288159 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 288173 288173 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 288174 288174 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We aim to observe the infertility or erectile dysfunction status in NASH patients. Since most NASH patients have accompanying metabolic syndrome we also aim to see how many NASH patients having metabolic syndrome have also high erectile dysfunction. Participants are assessed on one occasion only over a period of about 1 hour via the International Index of Erectile Function 5 point questionnaire.
Intervention code [1] 286056 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288360 0
Primary outcome 1: Total score of "International Index of Erectile Function"
Timepoint [1] 288360 0
Time Point: Baseline (at the enrollement phase)
Primary outcome [2] 288376 0
Primary outcome 2: Level of liver damage assessed by the liver biopsy.
Timepoint [2] 288376 0
Time Point: Baseline (at the enrollement phase)
Secondary outcome [1] 299959 0
Secondary outcome: Demographic findings and the presence of accompanying metabolic syndrome in each patient. Metabolic syndrome will be assessed by the insulin resistance blood sugar and lipid profiles in serum and routine measurements of blood tension, body weight, height, hip and waist circumference.
Timepoint [1] 299959 0
Time Point: Baseline (at the enrollement phase)

Eligibility
Key inclusion criteria
Male patients with Nonalcoholic steatohepatitis.
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Female patients
Patients who have overt diabetes that use oral antidiabetic agents or insulin
Patients using antihyperlipidemic agents, antihypertensives, testesteron derivatives
Chronic liver disease due to the causes other than Nonalcoholic steatohepatitis, such as chronic hepatitis B, C, alcohol, hemachromatosis, Wilson's disease
Diagnosed malignant disease

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4681 0
Turkey
State/province [1] 4681 0
Istanbul

Funding & Sponsors
Funding source category [1] 286329 0
Self funded/Unfunded
Name [1] 286329 0
Country [1] 286329 0
Turkey
Primary sponsor type
University
Name
Marmara University Faculty of Medicine
Address
T.C. Saglik Bakanligi, Marmara Universitesi Pendik E.A.H.
Mimar Sinan Caddesi No: 41

34780 Ust Kaynarca, Pendik, Istanbul
Country
Turkey
Secondary sponsor category [1] 285118 0
None
Name [1] 285118 0
Address [1] 285118 0
Country [1] 285118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288405 0
Marmara University, Medical School Ethics Committee
Ethics committee address [1] 288405 0
Tibbiye Cad. No:38
34668 Haydarpasa - Istanbul
Ethics committee country [1] 288405 0
Turkey
Date submitted for ethics approval [1] 288405 0
Approval date [1] 288405 0
15/09/2011
Ethics approval number [1] 288405 0
B.30.2.MAR.0.01.02/AEK/114

Summary
Brief summary
Previously, the incidence of erectile dysfunction has been shown to be increased in patients having metabolic syndrome (MS). Nonalcoholic steatohepatitis (NASH) is a clinical entity which was advocated as the liver manifestation of MS. We aim to screen the male NASH patients with regard to erectile dysfunction using the 5 point International Index of Erectile Function (IIEF-5) questionnaire.
Our secondary end point is to evaluate the demographic findings of NASH patients and test the association of erectile dysfunction with the components of MS.
Our secondary end point is to evaluate the demographic findings of NASH patients and test the assciation of erectile dysfunction with the components of MS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34952 0
Address 34952 0
Country 34952 0
Phone 34952 0
Fax 34952 0
Email 34952 0
Contact person for public queries
Name 18199 0
Deniz Guney Duman
Address 18199 0
T.C. S. B. Marmara Universitesi Pendik E.A.H. Gastroenteroloji Bolumu, Fevzi Cakmak Mah. Mimar Sinan Cad. No:41 Ust Kaynarca 34780 Pendik/ISTANBUL
Country 18199 0
Turkey
Phone 18199 0
+90 216 6254684
Fax 18199 0
Email 18199 0
[email protected]
Contact person for scientific queries
Name 9127 0
Deniz Guney Duman
Address 9127 0
T.C. S. B. Marmara Universitesi Pendik E.A.H. Gastroenteroloji Bolumu, Fevzi Cakmak Mah. Mimar Sinan Cad. No:41 Ust Kaynarca 34780 Pendik/ISTANBUL
Country 9127 0
Turkey
Phone 9127 0
+90 216 6254684
Fax 9127 0
Email 9127 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.