Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351683
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-01
Brief Title:
Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
Sponsor:
Iman Al-Naggar PhD
Organization:
UConn Health
Study Overview
Official Title:
Mito-LUTS A Pilot Study of the Effect of MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mito-LUTS
Brief Summary:
The goal of this clinical trial is to test the effect of a supplement called MitoQ mitoquinol mesylate on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome The main questions it aims to answer are
Is the study design feasible and acceptable to participants
Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo a look-alike substance that contains no drug
Participants will take 2 capsules of the study drug every morning for 4 months answer many questions about their health including questions about their bladder health perform physical and cognitive testing give blood and urine samples collect urine over 24 hour periods 3 times over the 4 months of the study complete 3 day bladder diaries about how much they drink and void undergo electrocardiograms have their vitals and measurements weight height waist circumference taken participate in 4 visits to the clinical research area and participate in many phone calls of varying length Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms urgency frequency nocturia incontinence etc
Is the study design feasible and acceptable to participants
Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo a look-alike substance that contains no drug
Participants will take 2 capsules of the study drug every morning for 4 months answer many questions about their health including questions about their bladder health perform physical and cognitive testing give blood and urine samples collect urine over 24 hour periods 3 times over the 4 months of the study complete 3 day bladder diaries about how much they drink and void undergo electrocardiograms have their vitals and measurements weight height waist circumference taken participate in 4 visits to the clinical research area and participate in many phone calls of varying length Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms urgency frequency nocturia incontinence etc
Detailed Description:
Both aging and the metabolic syndrome are risk factors for lower urinary tract symptoms LUTS including urgency frequency nocturia nighttime urination and incontinence This study aims to test whether an oral supplement that targets biological aging pathways can improve lower urinary tract symptoms LUTS in women aged 50-75 with the metabolic syndrome a cluster of conditions that occur together increasing the risk of heart disease stroke and type 2 diabetes MitoQ a strong mitochondrial-targeted antioxidant molecule has been shown to target mitochondrial dysfunction oxidative stress inflammation and endothelial dysfunction all aging pathways that are also found to be dysregulated in conditions that cause LUTS such as the overactive bladder syndrome Women aged 50-75 who have the metabolic syndrome per the new International Diabetes Federation IDF definition and have had urinary urgency for at least 3 months will be invited to participate in the study They will be screened by phone for major study inclusionexclusion criteria and then invited for an in-person screening visit where blood will be drawn and measurements taken to confirm eligibility Once eligible participants will be randomly assigned to MitoQ or placebo 2MitoQ1placebo and asked to take 2 capsules daily 40mg MitoQ total 30 minutes before breakfast for 4 months Participants will come back for study visits at 8 and 16 weeks and will receive two study data collection phone calls at 4 and 12 weeks where they will answer questions about their bladder There will be many other shorter phone calls throughout the study to check for adherence and adverse events In addition to questionnaires assessing bladder function participants will undergo tests of frailty physical function cognitive function and asked many questions about their health and medication We will also draw blood for safety assessment and to measure aging molecules in the blood at each visit and see whether they change with treatment Urine will also be collected at each study visit and participants will be asked to collect urine at home first morning and 24-hour urine and bring it to each of their study visits which will be used for measuring aging molecules and testing how they change with the study drug Participants will also fill out three-day voiding diaries to provide information about their voiding and LUTS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG067988 | NIH | None | httpsreporternihgovquickSearchP30AG067988 |