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The new gestational triad: hyperglycemia, urinary incontinence (UI) and biomolecular profile as a long-term predictor for UI: a prospective cohort study: translational research with biodevice with stem cells for muscle regeneration in diabetic rats

Grant number: 16/01743-5
Support type:Research Projects - Thematic Grants
Duration: April 01, 2017 - March 31, 2022
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Marilza Vieira Cunha Rudge
Grantee:Marilza Vieira Cunha Rudge
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
Co-Principal Investigators:Adonis Khezaee Hijas ; Angélica Mércia Pascon Barbosa ; Fátima Pereira de Souza ; Iracema de Mattos Paranhos Calderon ; Luis Alberto Sobrevia Luarte
Assoc. researchers:Álvaro Nagib Atallah ; Carlos Frederico de Oliveira Graeff ; Carlos Izaias Sartorão Filho ; Caroline Baldini Prudencio ; Daisy Maria Favero Salvadori ; Edson Assunção Mareco ; Fabiane Affonso Pinheiro ; Fernanda Piculo ; Gabriela Andrade Piemonte Lopes ; Gabriela Marini Prata ; Giovana Vesentini ; Juliana Ferreira Floriano ; Maeli Dal Pai ; Manoel João Batista Castello Girão ; Mario Sergio Palma ; Patrícia de Souza Rossignoli ; Raghuvir Krishnaswamy Arni ; Roberto Antonio de Araujo Costa ; Rondinelli Donizetti Herculano ; Selma Maria Michelin Matheus ; Sérgio Luis Felisbino ; Silvana Andrea Molina Lima ; Sofia Beatriz Carolina Vega Quiroz ; Spencer Luiz Marques Payão ; Sthefanie Kenickel Nunes ; Tawana Pascon ; Walnei Fernandes Barbosa
Associated grant(s):18/22406-2 - Exosomes in gestational Diabetes Mellitus, AP.R
Associated scholarship(s):18/07342-8 - Development of microfluidic devices/organ on a chip using xurography, poliester-toner and gelatin methacryloyl (GelMA), BE.PQ
19/04424-6 - The new gestational triad: hyperglycemia, urinary incontinence (ui) and biomolecular profile as a long-term predictor for ui: a prospective cohort study: translational research with biodevice with stem cells for muscle regeneration in rats, BP.IC
18/25153-8 - Gestational triad hyperglycemia cohort urinary incontinence and clinical molecular and omic profile of hyperglycemic myopathy in the prediction of incontinence and muscle dysfunction and translational research with biodevic for muscle regeneration in rats, BP.IC
+ associated scholarships 19/05710-2 - Prospective cohort of the omic biomarkers of the abdominal rectus muscle of pregnant women with hyperglycemia and pregnancy-specific urinary incontinence as predictors of urinary incontinence 6-12 months postpartum, BP.PD
18/25222-0 - The new gestational triad: hyperglycemia, urinary incontinence (ui) and biomolecular profile as a long-term predictor for ui: a prospective cohort study. translational research with biodevice with stem cells for muscle regeneration in diabetic rats, BP.IC
19/04278-0 - Training and improvement in the preparation, installation and monitoring of latex membrane biodevic as a support for post-pregnancy mesenchymal stem cells of diabetic rats, BP.TT
18/14136-5 - Cohort study of the gestational triad hyperglycemia, urinary incontinence and clinical, molecular and omic profile of the hyperglycemic myopathy in the prediction of incontinence, BP.IC
18/02979-8 - Prospective cohort of biochemical, protein and immunohistochemical markers of muscle fiber and extracellular matrix of the rectus abdominis muscle of Hyperglycemia and gestational-specific urinary incontinence as predictor of UI 6-12 months post-cesarean, BP.PD
18/17534-1 - Training and improvement in the implementation of standards for systematic review of Collaboration Cochrane on exercise effectiveness on pelvic floor muscle dysfunction and pregnancy-specific urinary incontinence of hyperglycemic pregnant women, BP.TT
18/10661-8 - Gestational triad hyperglycemia cohort, urinary incontinence and clinical profile, molecular and omic of hyperglycemic myopathy in the prediction of incontinence and muscle dysfunction and translational research with biodevic for muscle regeneration in ra, BP.PD
18/03361-8 - Morphological analysis of rectus abdominis and urethral striated muscles of diabetic pregnant rats submitted to exercise in aquatic environment, BP.MS
18/04736-5 - Prospective cohort study of omics biomarkers of rectus abdominis muscle from hyperglycemic pregnant women with urinary incontinence as predictive of urinary incontinence 6-12 months after postpartum, BP.PD
18/01687-3 - To train and improve techniques for biochemical determination of the levels of relaxin, calcium, calcitonin, parathyroid hormone, vitamin D, glucose and insulin in pregnant women, BP.TT
18/01686-7 - Training and improvement in the preparation, installation and monitoring of latex membrane biodevic as a support for post-pregnancy mesenchymal stem cells of diabetic rats, BP.TT
17/02518-8 - Development of polymer blends of latex-alginate and latex-collagen for tissue engineering application, BP.DR
17/21783-4 - Gestational triad cohort: hyperglycemia, urinary incontinence and clinical, molecular and omic profile of hyperglycemic myopathy in predicting incontinence and muscle dysfunction and translational research with biodevice for muscle regeneration in rats, BP.PD
17/11077-5 - A gestational triad cohort study: hyperglycemia, urinary incontinence and biomolecular profile as a long-term predictor for incontinence and muscular disfunction and translational research with biodevice for muscle regeneration in rats, BP.IC
17/09179-4 - The new gestational triad: hyperglycemia, urinary incontinence (UI) and biomolecular profile as a long-term predictor for UI: a prospective cohort study: translational research with biodevice with stem cells for muscle regeneration in rats, BP.IC
17/11076-9 - The new gestational triad: hyperglycemia, urinary incontinence (UI) and biomolecular profile as a long-term predictor for UI: a prospective cohort study: translational research with biodevice with stem cells for muscle regeneration in rats, BP.IC - associated scholarships

Abstract

The research group "Diabetes and pregnancy - clinical and experimental", in the Botucatu Medical School, has investigated since 2006 the pathophysiology of Gestational Diabetes (GDM) and Mild Gestational Hyperglycemia (MGH) and their relationships with Pelvic Floor Muscle Dysfunction (PFMD) and Urinary Incontinence (UI) in clinical and experimental studies. After critical analysis with national and international partners, it was observed that there were some gaps that need to be filled with pre-clinical and clinical complex studies. Objectives: To analyze the influence of the association between Gestational Hyperglycemia (HG) considering GDM and MGH, "Pregnacy-Specific UI (PSUI)" and profile (morphological, functional, biochemical, molecular and OMICs) of Gestational Hyperglycemic Myopathy (GHM) in the Rectus Abdominis Muscles (RAM) and Pelvic Floor Muscles (PFM); analyze the triad, HG, "PSUI" and profile of the GHM, the incidence of UI 6-12 months postpartum and morphological, functional and biochemical profile, within the four cohorts formed by the combination of HG and "PSUI"; to evaluate the effect of a latex biodevice coated with mesenchymal stem cells in the regeneration of urethral muscle and RAM after cesarean section in pregnant rats with moderate diabetes in morphological profile, microvascular, molecular and OMICs; and determine the scientific evidence through systematic review of the effectiveness of exercise on the PFMD and "PSUI" in pregnant women with HG. Materials and Methods: In the clinical study, participants will be selected from January 2016 to December 2019 in the Perinatal Diabetes Research Center of UNESP, at the Maternal Hospital - FAMEMA and the Regional Hospital of Assis City. The total number of participants will be 160, considering the four cohorts that will be constituted. Biochemical analysis will be performed on blood samples obtained from the study participants, to ascertain the levels of CCL7, Relaxin, Ca, PTH, calcitonin, vitamin D, glucose and insulin. In terms of the PFMs, the following evaluations will be conducted: functional assessment of pelvic floor, Electromyography (EMG) and Ultrasound (US). In terms of the RAM, the following evaluations will be conducted: EMG and US, at the time of cesarean ex vivo contractility obtained by myograph, and morphological profiles (ultrastructure of muscle fibers and extracellular matrix), molecular (gene and protein expression in muscle fibers and extracellular matrix) and OMICs (transcriptomics, proteomics and metabolomics). For the experimental study, pregnant Wistar rats divided into groups will be used (n=20 each), non-diabetic and diabetic, to undergo the the installation of a biodevice of latex membrane coated mesenchymal stem cells implanted into the urethral striated muscle and RAM. The systematic review study will follow the accepted rules and be registered with the Cochrane Collaboration. For statistical analysis, associations will be considered statistically significant at p <0.05. Analysis will be done with SPSS v21.0 software. Expected Results: To characterize the GHM; that the proposed triad is a predictor of UI and PFMD after 6-12 months post-partum; to establish markers for diagnosis and future therapies; to highlight the first line of preventive or rehabilitative intervention for muscle dysfunction and "PSUI"; that "PSUI" in pregnant women with GH be included and considered a public health problem as well as a clinical complication, and thus represent a new tool in defining the long-term maternal impact; and that the biodevice be considered for muscle regeneration in future clinical trials; and that this proposed translational approach will bring this research to the forefront of knowledge in Women's Health, once as yet unpublished analysis methodologies can be applied in areas that complement the problematic approach of medical/social interest. (AU)

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