NCT03608813

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

July 24, 2018

Last Update Submit

August 1, 2018

Conditions

PCOS

Keywords

Metabolomics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Controls

Healthy subjects

Other: Serum Metabolomics profiling

Case

PCOS affected subjects

Other: Serum Metabolomics profiling

Interventions

Serum Metabolomics profilingOTHER

Untargeted serum metabolomics profiling

CaseControls

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young women with a PCOS diagnosis without intercurrent chronic illness and a matched healthy population.

You may qualify if:

  • overweight/obesity (BMI \> 25 kg/m2);
  • absence of any other acute intercurrent or chronic illness;
  • a positive diagnosis of PCOS according to Rotterdam criteria.

You may not qualify if:

  • Use of hormonal medications or drugs that affect insulin sensitivity (e.g., inositols or metformin) before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 18950759BACKGROUND

  • 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. doi: 10.1210/jc.2003-032046.

    PMID: 15181052BACKGROUND

  • 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.

    PMID: 22153789BACKGROUND

  • 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. doi: 10.1016/j.fertnstert.2003.10.004.

    PMID: 14711538BACKGROUND

  • 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.

    PMID: 28642705BACKGROUND

  • 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.

    PMID: 29235868BACKGROUND

  • Troisi J, Cinque C, Giugliano L, Symes S, Richards S, Adair D, Cavallo P, Sarno L, Scala G, Caiazza M, Guida M. Metabolomic change due to combined treatment with myo-inositol, D-chiro-inositol and glucomannan in polycystic ovarian syndrome patients: a pilot study. J Ovarian Res. 2019 Mar 23;12(1):25. doi: 10.1186/s13048-019-0500-x.

    PMID: 30904021DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Jacopo Troisi, CEO

    Theoreo Srl

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ob/Gyn Clinical Research Coordinator

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 1, 2018

Study Start

September 10, 2016

Primary Completion

September 10, 2016

Study Completion

July 31, 2017

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share