Urologic DiseasesNCT03750604
Central Obesity in Cases of OAB
A study testing visceral fat obesity (surface area and function) in people with Urologic Diseases and Overactive Bladder Syndrome, run by Mansoura University.
Trial summary
Obesity is not a homogeneous condition and that the regional distribution of adipose tissue is important to understanding the relation of obesity to disturbances in glucose and lipid metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases, Overactive Bladder Syndrome, Obesity, Abdominal
- What is being tested?
- visceral fat obesity (surface area and function)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Oct 2018
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with OAB between 18 and 40 years old.
- normal variant healthy donor as a control.
Who cannot join
- Patients who have any of the following:
- Age less than 18 or more than 40 years old
- Neurogenic detrusor overactivity
- evidence of obstructed flow in absence of prolapse
- mixed urinary incontinence
- associated urethral pathology, e.g. Urethral diverticulum
- Associated bladder pathology e.g. fistula, active urinary tract infection as evidenced by positive urine culture
- previous exposure for anticholinergics or BTX-A injection.
About this study
Official title: Central Obesity With Relation in OAB: Is it a Matter of Size or Fat Activity?. Prospective Controlled Trial
Obesity is not a homogeneous condition and that the regional distribution of adipose tissue is important to understanding the relation of obesity to disturbances in glucose and lipid metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat. Regional distribution appears to be an important indicator for metabolic alterations since an inconstant correlation between body mass index (BMI) and these disturbances have been found. Visceral obesity is associated with increased adipocytokine production, proinflammatory activity, deterioration of insulin sensitivity, increased risk of developing diabetes, "high-triglyceride/low-HDL cholesterol dyslipidemia," hypertension and atherosclerosis. It might be more precise to divide central abdominal fat into subcutaneous(S) and visceral (V) fat surface area and volume and even ratio (S/V); risk factors for cardiovascular disease, particularly those related to glucose and lipid metabolism and hypertension, being>0.4; with evaluation of visceral fat functionality by visceral adiposity index (VAI) with integration with lipid profile. Adding bladder wall thickness with perivesical fat as a factor may impair bladder function and contribute to dysregulation. The data on the association between central adiposity with OAB symptoms and Urodynamics is not mature.
Read the detailed description
Overactive bladder (OAB) is defined by international continence society (ICS) as urinary urgency with or without incontinence often associated with frequency and nocturia. As a chronic, unbearable condition, OAB has a deeply negative impact on QoL, including social, physical, psychological, occupational and sexual domains. Overactive bladder (OAB) is a highly prevalent symptom complex that is estimated to affect 12.8% of women and 10.8% of men.
The underlying pathophysiological mechanism of OAB and DO is poorly understood. It is thought that not only the detrusor muscle but also urothelium, peripheral afferent terminals, and pelvic blood vessels may play a role.
More recently, overweight and central obesity was found to be an independent risk factor for overactive bladder (OAB) in women. The most likely explanation is the occurrence of chronic inflammation in the bladder indicated by increased urinary chemokines. Adipocytes surrounding the human bladder can be affected, thus leading to inflammation and triggering OAB symptoms. Other authors showed that OAB is associated with increased BMI and increase of waist circumference at the upper end of the adiposity distribution for both men and women.
Obesity is not a homogeneous condition and that the regional distribution of adipose tissue is important to understanding the relation of obesity to disturbances in glucose and lipid metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat. Regional distribution appears to be an important indicator for metabolic alterations since an inconstant correlation between body mass index (BMI) and these disturbances have been found. Visceral obesity is associated with increased adipocytokine production, proinflammatory activity, deterioration of insulin sensitivity, increased risk of developing diabetes, "high-triglyceride/low-HDL cholesterol dyslipidemia," hypertension and atherosclerosis.
Away from that anthropometric measures as BMI, waist circumference (WC), waist to hip ratio (WHR) are crude measures for adiposity. WHR has been advocated as a measure of central obesity because BMI does not describe the distribution of obesity. This measurement, however, was found to be associated with SUI but not with OAB or mixed urinary incontinence, further suggesting a non-mechanical mechanism for OAB in obese women. WC is a major clinical parameter used for the indirect evaluation of increased visceral fat, In addition, WC showed shared variance with visceral adipose fat up to 75% (42) (38). Nevertheless, WC alone does not help in distinguishing between subcutaneous and visceral fat mass.
So, it might be more precise to divide central abdominal fat into subcutaneous(S) and visceral (V) fat surface area and volume and even ratio (S/V); risk factors for cardiovascular disease, particularly those related to glucose and lipid metabolism and hypertension, being>0.4; with evaluation of visceral fat functionality by visceral adiposity index (VAI) with integration with lipid profile. Adding bladder wall thickness with perivesical fat as a factor may impair bladder function and contribute to dysregulation.
The data on the association between central adiposity with OAB symptoms and Urodynamics is not mature. So, the investigators intend to conduct this study evaluating the surface area of both subcutaneous and visceral fat and its functionality with incorporation with lipid profile and bladder wall thickness and perivesical fat.
- Being tested
- visceral fat obesity (surface area and function)
- Keywords
- abdominal obesity, OAB
- Medical subject headings
- Urologic Diseases, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visceral fat obesity (surface area and function)Diagnostic test
WC is evaluated at the midpoint between the lower border of the rib cage and the iliac crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels.
Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.
And in males:
VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL WC: waist circumference, BMI: body mass index, TG: triglyceride, HDL: high-density lipoprotein
| Study group | Role | What they receive |
|---|---|---|
| patients with OAB | Active comparator | Patients were asked to fill (OABSS) for more accurate evaluation of bothersome degree. Waist Circumference is evaluated. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to CT detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.
And in males:
VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL Receives: Diagnostic Test: visceral fat obesity (surface area and function) |
| normal variants healthy without symptoms | Placebo comparator | WC is evaluated crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL Receives: Diagnostic Test: visceral fat obesity (surface area and function) |
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between visceral fat and and severity of OAB symptoms.
using OAB symptoms scores(OABSS) with total score 15(mild<5,mod (5-10),sever>10) in relation to visceral fat surface area in cm2 by NCCT measurement.
Measured: 2 years
Relation of OAB symptoms to visceral fat function
using of OABSS total score 15(mild<5, mod(5-10), sever>10) to visceral fat function (VAI)(VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Jan 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelbaset, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750604
- Sponsor's protocol ID
- obesity in OAB
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Obesity With Relation in OAB: Is it a Matter of Size or Fat Activity?. Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT03750604
- Acronym / sponsor ID
- obesity in OAB
- Keywords
- abdominal obesity, OAB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 23 Nov 2018 (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.
Obesity is not a homogeneous condition and that the regional distribution of adipose tissue is important to understanding the relation of obesity to disturbances in glucose and lipid metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat. Regional distribution appears to be an important indicator for metabolic alterations since an inconstant correlation between body mass index (BMI) and these disturbances have been found. Visceral obesity is associated with increased adipocytokine production, proinflammatory activity, deterioration of insulin sensitivity, increased risk of developing diabetes, "high-triglyceride/low-HDL cholesterol dyslipidemia," hypertension and atherosclerosis. It might be more precise to divide central abdominal fat into subcutaneous(S) and visceral (V) fat surface area and volume and even ratio (S/V); risk factors for cardiovascular disease, particularly those related to glucose and lipid metabolism and hypertension, being>0.4; with evaluation of visceral fat functionality by visceral adiposity index (VAI) with integration with lipid profile. Adding bladder wall thickness with perivesical fat as a factor may impair bladder function and contribute to dysregulation. The data on the association between central adiposity with OAB symptoms and Urodynamics is not mature.
Detailed description
Overactive bladder (OAB) is defined by international continence society (ICS) as urinary urgency with or without incontinence often associated with frequency and nocturia. As a chronic, unbearable condition, OAB has a deeply negative impact on QoL, including social, physical, psychological, occupational and sexual domains. Overactive bladder (OAB) is a highly prevalent symptom complex that is estimated to affect 12.8% of women and 10.8% of men.
The underlying pathophysiological mechanism of OAB and DO is poorly understood. It is thought that not only the detrusor muscle but also urothelium, peripheral afferent terminals, and pelvic blood vessels may play a role.
More recently, overweight and central obesity was found to be an independent risk factor for overactive bladder (OAB) in women. The most likely explanation is the occurrence of chronic inflammation in the bladder indicated by increased urinary chemokines. Adipocytes surrounding the human bladder can be affected, thus leading to inflammation and triggering OAB symptoms. Other authors showed that OAB is associated with increased BMI and increase of waist circumference at the upper end of the adiposity distribution for both men and women.
Obesity is not a homogeneous condition and that the regional distribution of adipose tissue is important to understanding the relation of obesity to disturbances in glucose and lipid metabolism. Central abdominal fat is composed of abdominal subcutaneous fat and visceral fat. Regional distribution appears to be an important indicator for metabolic alterations since an inconstant correlation between body mass index (BMI) and these disturbances have been found. Visceral obesity is associated with increased adipocytokine production, proinflammatory activity, deterioration of insulin sensitivity, increased risk of developing diabetes, "high-triglyceride/low-HDL cholesterol dyslipidemia," hypertension and atherosclerosis.
Away from that anthropometric measures as BMI, waist circumference (WC), waist to hip ratio (WHR) are crude measures for adiposity. WHR has been advocated as a measure of central obesity because BMI does not describe the distribution of obesity. This measurement, however, was found to be associated with SUI but not with OAB or mixed urinary incontinence, further suggesting a non-mechanical mechanism for OAB in obese women. WC is a major clinical parameter used for the indirect evaluation of increased visceral fat, In addition, WC showed shared variance with visceral adipose fat up to 75% (42) (38). Nevertheless, WC alone does not help in distinguishing between subcutaneous and visceral fat mass.
So, it might be more precise to divide central abdominal fat into subcutaneous(S) and visceral (V) fat surface area and volume and even ratio (S/V); risk factors for cardiovascular disease, particularly those related to glucose and lipid metabolism and hypertension, being>0.4; with evaluation of visceral fat functionality by visceral adiposity index (VAI) with integration with lipid profile. Adding bladder wall thickness with perivesical fat as a factor may impair bladder function and contribute to dysregulation.
The data on the association between central adiposity with OAB symptoms and Urodynamics is not mature. So, the investigators intend to conduct this study evaluating the surface area of both subcutaneous and visceral fat and its functionality with incorporation with lipid profile and bladder wall thickness and perivesical fat.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with OAB | Active comparator | Diagnostic Test: visceral fat obesity (surface area and function)Patients were asked to fill (OABSS) for more accurate evaluation of bothersome degree. Waist Circumference is evaluated. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to CT detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study. VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males: VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL |
| normal variants healthy without symptoms | Placebo comparator | Diagnostic Test: visceral fat obesity (surface area and function)WC is evaluated crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study. VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with OAB between 18 and 40 years old.
- normal variant healthy donor as a control.
Key exclusion criteria (8 listed)
- Patients who have any of the following:
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 |
|---|---|---|
| visceral fat obesity (surface area and function)WC is evaluated at the midpoint between the lower border of the rib cage and the iliac crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels. Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study. VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males: VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL WC: waist circumference, BMI: body mass index, TG: triglyceride, HDL: high-density lipoprotein | Diagnostic test | normal variants healthy without symptoms, patients with OAB |
Primary outcome
relation between visceral fat and and severity of OAB symptoms.
Time frame: 2 years
using OAB symptoms scores(OABSS) with total score 15(mild<5,mod (5-10),sever>10) in relation to visceral fat surface area in cm2 by NCCT measurement.
Relation of OAB symptoms to visceral fat function
Time frame: 2 years
using of OABSS total score 15(mild<5, mod(5-10), sever>10) to visceral fat function (VAI)(VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL. And in males:VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL)
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 23 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing visceral fat obesity (surface area and function) in people with Urologic Diseases and Overactive Bladder Syndrome, run by Mansoura 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 2 inclusion and 8 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 23 Nov 2018. 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. Some participants in this study may receive a placebo. 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?
relation between visceral fat and and severity of OAB symptoms. (time frame: 2 years). The study lists 2 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 23 Nov 2018.