NCT00779571已完成不适用
Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
The Hospital of Vestfold1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2008年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This study has two phases:
- In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
- In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.
详细描述
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman (European Caucasian)
- •BMI = or > 35
排除标准
- •Cushing syndrome
- •Adrenal hyperplasia
- •Androgen-producing tumors
- •Anovulation caused by hyperprolactinemia
- •Pregnancy, breast feeding
- •Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
研究组 & 干预措施
Crispbread
Experimental
Intervention: Crispbread LCD
干预措施: Crispbread (Behavioral)
Liquid meal replacement
Active Comparator
Intervention: LMR LCD
干预措施: Crispbread (Behavioral)
结局指标
主要结局
Weight loss
时间窗: One year
次要结局
- Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors(one year)
研究者
Line Kristin Johnson
MSc, PhD
The Hospital of Vestfold
研究点 (1)
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