Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
Testing two different strategies for weight loss intervention and revealing possible changes in composition of gut microbiota, in order to provide more insight in the effect of dietary changes and weight loss treatments on gut microbiome in overweight and obese women with polycystic ovary syndrome (PCOS). The two strategies are:
- dietary advice plus myo-inositol and folic acid
- dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome with interventions.
Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of treatment.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS according to ROtterdam criteria
- •BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2
排除标准
- •pregnancy
- •pancreatitis (in the past)
- •oral contraceptive pill use
- •inflammatory bowel disease
- •auto-immune disease
- •immuno-modulatory drugs
- •antidiabetic drugs
- •anti-inflammatory drugs
研究组 & 干预措施
dietary advice plus myo-inositol and folic acid
2gram myo-inositol and folic acid twice daily orally lack of consistent evidence for myo-inositol as treatment of women with PCOS
干预措施: dietary advice plus myo-inositol and folic acid (Dietary Supplement)
dietary advice plus liraglutide pen injector
liraglutide starting at 0.6 mg, gradually increasing up to a dose of 3 mg daily after four weeks no evidence for weight loss in women with PCOS
干预措施: dietary advice plus Liraglutide Pen Injector (Drug)
结局指标
主要结局
weight loss
时间窗: 32 weeks
次要结局
未报告次要终点