Central Obesity in Cases of OAB

NCT03750604 | Completed

• 1 other identifier: obesity in OAB
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Urologic Diseases; Overactive Bladder Syndrome; Obesity, Abdominal

Keywords

abdominal obesity; OAB

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  2 years

Study Arms (2)

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

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

Diagnostic Test: visceral fat obesity (surface area and function)

Interventions

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

normal variants healthy without symptoms; patients with OAB

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with OAB between 18 and 40 years old.
• normal variant healthy donor as a control.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Urologic Diseases; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 23, 2018
• Study Start: January 1, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11