PCOS Clinical Trial
Official title:
Effects of a Combined Treatment With Myo-inositol, D-chiro-inositol and Glucomannan in Women With PCOS
NCT number | NCT03608813 |
Other study ID # | PCOS-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 10, 2016 |
Est. completion date | July 31, 2017 |
Verified date | August 2018 |
Source | University of Salerno |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to analyze the metabolic profiles in women with PCOS before and after 3 months of therapy with a combination of myo-inositol, D-chiro-inositol and glucomannan, and compare these data with a group of healthy control women.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 31, 2017 |
Est. primary completion date | September 10, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - overweight/obesity (BMI > 25 kg/m2); - absence of any other acute intercurrent or chronic illness; - a positive diagnosis of PCOS according to Rotterdam criteria. Exclusion Criteria: - Use of hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Salerno | Theoreo Srl |
Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23. Review. — View Citation
Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004 Jun;89(6):2745-9. — View Citation
Fauser BC, Tarlatzis BC, Rebar RW, Legro RS, Balen AH, Lobo R, Carmina E, Chang J, Yildiz BO, Laven JS, Boivin J, Petraglia F, Wijeyeratne CN, Norman RJ, Dunaif A, Franks S, Wild RA, Dumesic D, Barnhart K. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Fertil Steril. 2012 Jan;97(1):28-38.e25. doi: 10.1016/j.fertnstert.2011.09.024. Epub 2011 Dec 6. — View Citation
Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. — View Citation
Sortino MA, Salomone S, Carruba MO, Drago F. Polycystic Ovary Syndrome: Insights into the Therapeutic Approach with Inositols. Front Pharmacol. 2017 Jun 8;8:341. doi: 10.3389/fphar.2017.00341. eCollection 2017. Review. — View Citation
Troisi J, Sarno L, Landolfi A, Scala G, Martinelli P, Venturella R, Di Cello A, Zullo F, Guida M. Metabolomic Signature of Endometrial Cancer. J Proteome Res. 2018 Feb 2;17(2):804-812. doi: 10.1021/acs.jproteome.7b00503. Epub 2018 Jan 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Untargeted serum metabolomics profiling | Identify a complex network of serum molecules that appear to be correlated with PCOS, and with a combined treatment with inositols and glucomannan. | 6 months |
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