Clinical Trials Directory

Trials / Completed

CompletedNCT01548105

Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse

Status
Completed
Phase
Study type
Observational
Enrollment
96 (actual)
Sponsor
TriHealth Inc. · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.

Detailed description

Tissue destructive disorders are more common in smokers than in non-smokers. Alterations in wound healing and connective tissue turnover are suggested mechanisms, but exact details remain to be discovered. The synthesis of subcutaneous collagen in smokers is specifically impeded, and that smokers have less collagen compared to non-smokers. Jorgensen et al study showed that smokers tend to have less procollagen I N-propeptide (PINP) levels in the blood, less vitamin C and higher levels of matrix metalloproteinase (MMP-9), these findings reversed after smoking cessation. Since smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.

Conditions

Interventions

TypeNameDescription
OTHERBlood draw for the study participantsThese will include: * Procollagen 1-N propeptide levels (PINP) * Matrix metalloproteinase (MMP9) * Plasma Vitamin C levels

Timeline

Start date
2012-03-01
Primary completion
2013-01-01
Completion
2013-03-01
First posted
2012-03-08
Last updated
2014-10-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01548105. Inclusion in this directory is not an endorsement.