ISRCTN36687466已完成未知
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 个研究点目标入组 20 人开始时间: 2017年4月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
- •11. Weight loss of >5 kg within the last 6 months
- •12. A history of gallstones/gout ( diet may raise urate levels)
- •13. Substance abuse
- •14. Known cancer
- •15. Soya intolerance
- •16. Current treatment with anti-obesity drugs
- •17. Diagnosed eating disorder or purging in the last 12 months, based on patient reporting or results of EDI-3 RF questionnaire interpreted by clinical psychologist.
- •18. Pregnant/ considering pregnancy
- •19. Participants who have required hospitalisation for depression or are on antipsychotic drugs
- •20. Peri- or post-menopausal women
- •21. Lactating women
- •22. Lactose intolerance
- •23. Acute illness
- •24. Prescribed oral steroids or other medication that may affect appetite
- •25. Hospitalised subjects within 3 months of admission to the study
- •26. Participation in any other clinical interventional studies in the last 3 months
研究者
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