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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132545
• Other study ID #: ARMOC
• Status: Completed
• Phase: N/A
• First received: April 24, 2017
• Last updated: April 24, 2017
• Start date: January 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• SenseWear Armband (SWA) monitoring
Participants wore the SWA on their right arm
• total body dual-energy X-ray absorptiometry
DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in resting metabolic rate		2 days
Secondary	differences in body fat distribution		1 day