ISRCTN36687466
Completed
未知
A randomised controlled trial to investigate the effect of very low calorie diet (VLCD) vs. an energy deficit approach weight loss diet, over 8 weeks, in obese women with polycystic ovarian syndrome (PCOS)
Hull and East Yorkshire Hospitals0 sites20 target enrollmentApril 24, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- PCOS and obesity
- Sponsor
- Hull and East Yorkshire Hospitals
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2021 Abstract results in https://doi.org/10.1530/endoabs.77.P107 (added 18/02/2022) 2023 Results article in https://doi.org/10.3390/nu15183872 (added 10/05/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Women, aged 18\-45 years (inclusive)
- •2\. Individuals wishing to lose weight
- •3\. Body Mass Index (BMI)\=30 kg/m2 and \<45 kg/m2
- •4\. Have a reliable form of contraception in place
- •5\. Confirmed diagnosis of PCOS based on Rotterdam criteria
- •6\. Willing to commit to 18 weeks of no alcohol and significant alterations to their social life e.g. eating out, holidays, and celebrations
Exclusion Criteria
- •1\. Non\-classical 21\-hydroxylase deficiency, hyperprolactinaemia, Cushing’s disease and androgen\-secreting tumours will be excluded by appropriate tests
- •2\. Any concurrent illness including type 2 diabetes
- •3\. Subjects who are on any of the following medications within 3 months of recruitment
- •4\. Metformin or other insulin\-sensitizing medications (e.g., pioglitazone). If cessation of the drug is agreed between the medics and the patient, in preparation for the trial an 8 week washout is required.
- •5\. Hormonal contraceptives (e.g., birth control pills, hormone\-releasing implants, etc.). Subjects will be advised to use barrier contraception during the study period. If cessation of the drug is agreed between the medics and the patient, in preparation for the trial a 4 week washout is required.
- •6\. Anti\-androgens (e.g., spironolactone, flutamide, finasteride, etc.). If cessation of the drug is agreed between the medics and the patient, in preparation for the trial a 8 week washout is required.
- •7\. Clomiphene citrate or estrogen modulators such as letrozole
- •8\. GnRH modulators such as leuprolide
- •9\. Minoxidil
- •10\. Women planning to conceive.
Outcomes
Primary Outcomes
Not specified
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