Erectile DysfunctionNCT00636688
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial
A study testing Lifestyle - detailed advice in people with Erectile Dysfunction, run by University of Campania Luigi Vanvitelli.
Trial summary
Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Lifestyle - detailed advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Oct 2003
- Phase
- Interventional
- 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 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese, sedentary (<1 hour per week of physical activity) men with erectile dysfunction (a IIEF score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months
Who cannot join
- Diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL [7.8-11.1 mmol/L] 2 hours after a 75-g oral glucose load)
- Impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy
- Hypertension (blood pressure >140/90 mm Hg)
- Cardiovascular disease
- Psychiatric problems
- Use of drugs or alcohol abuse (500 g of alcohol per week in the last year).
About this study
Official title: Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.
Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.
Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF).
The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.
- Conditions
- Erectile Dysfunction
- Being tested
- Lifestyle - detailed advice, Control - general information
- Keywords
- Obesity, Lifestyle changes
- Medical subject headings
- Erectile Dysfunction, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle - detailed adviceBehavioural
Detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity
Control - general informationBehavioural
General information about healthy food choices and exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral (Lifestyle Counseling) Receives: Behavioral: Lifestyle - detailed advice |
| 2 | Active comparator | Control group Receives: Behavioral: Control - general information |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF (International Index Erectile Function)
Measured: two years
Secondary outcomes (1)
Endothelial function, Circulating inflammatory markers
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startOct 2000
- Primary completionApr 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Investigators
- Dario Giugliano, MD,PhD, Study director, Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636688
- Sponsor's protocol ID
- 05/2000
- Status last verified
- Mar 2008
- First submitted
- 26 Feb 2008
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. Sexual function in men older than 50 years of age: results from the health professionals follow-up study. Ann Intern Med. 2003 Aug 5;139(3):161-8. doi: 10.7326/0003-4819-139-3-200308050-00005.
PubMed 12899583Esposito K, Giugliano F, Di Palo C, Giugliano G, Marfella R, D'Andrea F, D'Armiento M, Giugliano D. Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial. JAMA. 2004 Jun 23;291(24):2978-84. doi: 10.1001/jama.291.24.2978.
PubMed 15213209
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00636688
- Acronym / sponsor ID
- 05/2000
- Conditions
- Erectile Dysfunction
- Keywords
- Obesity, Lifestyle changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Apr 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 14 Mar 2008 (estimated)
- 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.
Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.
Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF).
The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle - detailed adviceBehavioral (Lifestyle Counseling) |
| 2 | Active comparator | Behavioral: Control - general informationControl group |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obese, sedentary (<1 hour per week of physical activity) men with erectile dysfunction (a IIEF score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months
Key exclusion criteria (6 listed)
- Diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL [7.8-11.1 mmol/L] 2 hours after a 75-g oral glucose load)
- Impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy
- Hypertension (blood pressure >140/90 mm Hg)
- Cardiovascular disease
- Psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle - detailed adviceDetailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity | Behavioural | 1 |
| Control - general informationGeneral information about healthy food choices and exercise | Behavioural | 2 |
Primary outcome
IIEF (International Index Erectile Function)
Time frame: two years
1 secondary outcome
Endothelial function, Circulating inflammatory markers
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2008.
- Background: PubMed 12899583Bacon CG, Mittleman MA, Kawachi I, Giovannucci E, Glasser DB, Rimm EB. Sexual function in men older than 50 years of age: results from the health professionals follow-up study. Ann Intern Med. 2003 Aug 5;139(3):161-8. doi: 10.7326/0003-4819-139-3-200308050-00005.
- Results publication: PubMed 15213209Esposito K, Giugliano F, Di Palo C, Giugliano G, Marfella R, D'Andrea F, D'Armiento M, Giugliano D. Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial. JAMA. 2004 Jun 23;291(24):2978-84. doi: 10.1001/jama.291.24.2978.
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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.
Dario Giugliano, MD,PhD study director
Department of Geriatrics and Metabolic Diseases, SUN Naples, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle - detailed advice in people with Erectile Dysfunction, run by University of Campania Luigi Vanvitelli.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 18 Apr 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF (International Index Erectile Function) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636688, which also lists 2 linked publications.
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 18 Apr 2008.