Effect of Very Low Calorie Ketogenic Diet on Obese and Insulin-resistant Women With Polycystic Ovary Syndrome: a Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Body mass index
研究概览
简要总结
The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insulin resistance in obese and insulin resistant patients with Polycystic Ovary Syndrome
详细描述
Consecutive patients coming to the Endocrinology and Diabetes Clinic of the S.Orsola hospital in Bologna with the suspicion of PCOS, during the study period, will be eligible to participate. In the screening phase, patients from the clinic conforming to the inclusion criteria will be invited to participate in the anovulation screening phase, lasting up to 8 weeks, during which measurements of LH, FSH, estradiol, progesterone and a gynecologic ultrasound will be done on 7th, 14th, 21st and 28th day of the presumed ovulatory cycle, or at any time if amenorrhea present. Consenting participants will provide written informed consent.
Following the anovulation screening, the patients will be randomized in two arms of the study: 1. very low calorie ketogenic diet (VLCKD) and the 2. low calorie standard diet (LCD).
The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the nature of the study intervention.
The group assigned to the VLCKD will follow the VLCKD for 8 weeks, after which they will follow the LCD for the next 8 weeks.
The group assigned to the LCD will follow the LCD for the entire length of the study (16 weeks.)
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS according to the NIH criteria;
- •Body mass index (BMI) between 30 and 35 kg/m3;
- •HOMA index ≥ 3 (according to formula: (fasting glucose [mmol/L] × fasting insulin [mIU/L])/22.5)
- •Written informed consent.
排除标准
- •Diabetes type 1
- •Exogenous insulin or insulin analogue therapy
- •Obesity caused by endocrine disease other than PCOS
- •Obesity caused by pharmacotherapy
- •Use of a weight-loss diet in the past 3 months
- •Use of contraceptive pills in the past 3 months
- •Severe depression
- •Other psychiatric diseases
- •Alcohol or psychoactive substance abuse
- •Severe hepatic insufficiency
- •Renal calculosis
- •Renal insufficiency
- •Episodes of gout
- •Malignant neoplasia
- •Previous cardiovascular or cerebrovascular events
- •Uncontrolled hypertension
- •Water-electrolyte imbalance
- •Any pharmacotherapy capable of interfering with glucose metabolism
- •Any pharmacotherapy capable of interfering with steroid metabolism
- •Menopause
- •Pregnancy
- •Lactation.
结局指标
主要结局
Change in Body mass index
时间窗: 16 weeks after the start of treatment
Weight and height will be combined to report BMI in kg/m\^2
Change in body composition measured by bioimpedentiometry
时间窗: 16 weeks after the start of the treatment
Fat mass and lean mass changes will be considered to estimate change in body composition and reported as %
次要结局
- Change in Body mass index(8 weeks after the start of treatment)
- Change in Homeostasis Model Assessment Index(16 weeks after the start of the treatment)
- Change in frequency of menstrual cycles(16 weeks after the start of the treatment)
- Change in body composition measured by bioimpedentiometry(8 weeks after the start of the treatment)
- Change in hirsutism(16 weeks after the start of the treatment)
- Change in plasma concentrations of testosterone(16 weeks after the start of the treatment)
研究者
Alessandra Gambineri
Associate Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna