Anti-inflammatory dietary combo in overweight and obese women with polycystic ovary syndrome

Not Applicable

• Conditions: Fertility-female; polycystic ovary syndrome

• Registration Number: PACTR201502001001110
• Lead Sponsor: amany salama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Non-pregnant, overweight and obese adult females with PCOS, aged 20 ¿ 40 years

Exclusion Criteria

The following subjects were excluded from the study:
¿ Subjects having type 1 or type 2 diabetes.
¿ Subjects receiving metformin within the last month.
¿ Subjects receiving ovulation induction medications within the last month.
¿ Subjects following a diet regimen within the last month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effects of lifestyle modification with or without metformin on anthropometric, metabolic, endocrine and inflammatory markers in overweight and obese women with polycystic ovary syndrome.

Secondary Outcome Measures

Name	Time	Method
To assess the effects of dietary recalibration, exercise and behavioural modification with or without metformin on regain of menstrual cyclicity and spontaneous pregnancy rates, and to compare the value of Acute-phase serum amyloid A as a surrogate marker for prognostic evaluation of the metabokic profile in overwight and obese women with PCOS in relation to C-reactive protein (CRP)