Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome

April 24, 2017 updated by: Valeria Tagliaferri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
In a longitudinal, prospective and observational study, patients with PCOS and controls wore the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile were performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

group 1: women with PCOS diagnosed according with the Rotterdam Consensus Conference criteria group 2: healty women

Description

Inclusion Criteria:

  • . PCOS diagnosed according with the Rotterdam Consensus Conference criteria

Exclusion Criteria:

  • presence of a late-onset adrenal enzyme defect
  • Significant liver or renal impairment
  • pregnancy and nursing
  • neoplasm
  • cardiovascular disease
  • other hormonal dysfunctions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
controls
Diagnostic test: SenseWear Armband (SWA) monitoring
Participants wore the SWA on their right arm
Diagnostic test: total body dual-energy X-ray absorptiometry
DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue
PCOS
Diagnostic test: SenseWear Armband (SWA) monitoring
Participants wore the SWA on their right arm
Diagnostic test: total body dual-energy X-ray absorptiometry
DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
differences in resting metabolic rate
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
differences in body fat distribution
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARMOC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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