Weight loss in obese women with Polycystic Ovary Syndrome (PCOS)

Not Applicable

Completed

• Conditions: Obesity, polycystic ovarian syndrome/weight loss, fertility; Nutritional, Metabolic, Endocrine; Polycystic ovarian syndrome

• Registration Number: ISRCTN01915371
• Lead Sponsor: Robert Gordon University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-13
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1. Obese women body mass index (BMI) > 30 kg/m2
2. Aged between 20-40 years old who wish to conceive and have polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria, (2003)

Exclusion Criteria

1. Previously diagnosed diabetics (both types 1 and 2)
2. History of renal disorder, hepatic disease, thyroid disease or cancer
3. Eating disorders
4. Weight altering medication
5. Weight loss > 2% in the last 3 months
6. Major cardiovascular or cerebrovascular event in the last 6 months
7. Pregnancy or lactation
8. Miscarriage in the last 3 months
9. Following contraception methods
10. Cardiac dysrhythmia
11. Porphyria (disorder of certain enzymes in the haeme biosynthetic pathway)
12. Thrombosis
13. Total lactose intolerance
14. Convulsions, seizures, epilepsy
15. Major depressive episodes, psychotic episodes, schizophrenia
16. Serious illness, injury or trauma/surgery in the last 3 months or due to undergo surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Weight loss-will be measured with subjects wearing light clothing and no shoes, on a calibrated digital scale (Tanita Body Composition Analyzer, type BC 410 MA III)<br>2. Ovulation-A calendar will be provided for the patients to keep track of their menses for the 12 month duration of the study