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临床试验/NCT01475019
NCT01475019Unknown4 期

The Effect of Weight Loss With Orlistat or Sibutramine Administration , Hypocaloric Diet and Physical Exercise , on AMH Levels, in Women With Polycystic Ovary Syndrome

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
1
主要终点
Anti- Mullerian hormone (AMH) levels

研究概览

简要总结

The first aim of the investigators study, was to investigate the combined effect of diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH) levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.

The other aim of the investigators study, was to examine the effect of hypocaloric diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).

详细描述

The first aim of our study, was to investigate the combined effect of diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH) levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.

The study included sixty one (61) women with PCOS (mean age: 26.11±6.86 and mean body mass index: 34.83±6.39), matched for age and body mass index (BMI) with twenty (20) obese women without PCOS (mean age: 26.95±4.77 and mean BMI: 36.79±6.98). Diagnosis of PCOS was based on the 2003 Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus criteria.

Briefly, a moderate daily physical activity and a normal-protein, energy restricted diet were prescribed based on a calculated individual basal metabolic rate (BMR) of all women (BMR-600 kcal/d), for a period of 24 weeks. In addition, orlistat (Xenical, Roche S.A., Greece; 120 mg, 3 times per day) was administered before each meal, for 24 weeks. At baseline, week 12, and week 24, at 9:00 AM, after an overnight fast, subjects were weighed. Waist and hip circumferences were measured in duplicate. Blood samples were collected and the basal serum levels of AMH, FSH, LH, PRL, T, D4A, DHEAS, 17a-hydroxyprogesterone (17a-OHP), SHBG, glucose, and insulin were measured. AMH concentrations were measured with an enzymatically amplified two-sided immunoassay [DSL-10-14400 Active Müllerian Inhibiting Substance/AMH enzyme-linked immunosorbent assay (ELISA) kit, DSL Laboratories, Webster, TX]. The theoretical sensitivity of the method is 0.006 ng/ml, the intra-assay coefficient of variation for high values is 3.3% and the interassay coefficient of variation for high values is 6.7%.

We also studied the changes of mean number of follicles (expressed as the mean number of follicles of both ovaries= follicles of right ovary+ follicles of left ovary/2) and mean ovarian volume (expressed as the mean volume of both ovaries= volume of right ovary+ volume of left ovary/2).

The other aim of our study, was to examine the effect of hypocaloric diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).

研究设计

研究类型
Interventional
分配方式
Non 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 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • premenopausal,
  • nonpregnant,
  • nonlactating,
  • overweight and obese women

排除标准

  • classical 21-hydroxylase deficiency,
  • hyperprolactinemia,
  • adrenal or ovarian tumor and Cushing's disease

研究组 & 干预措施

PCOS obese Orlistat

Experimental

Obese PCOS women treated with Orlistat, diet and physical exercise

干预措施: Orlistat (Drug)

Obese Orlistat

Experimental

Obese women (non PCOS) treated with Orlistat, diet and physical exercise

干预措施: Orlistat (Drug)

PCOS obese diet

Experimental

Obese PCOS women treated with diet and physical exercise

干预措施: Diet and physical exercise (Behavioral)

PCOS obese Sibutramine

Experimental

Obese PCOS women treated with Sibutramine, diet and physical exercise

干预措施: Sibutramine (Drug)

结局指标

主要结局

Anti- Mullerian hormone (AMH) levels

时间窗: 6 months

次要结局

  • Weight loss(6 months)
  • Androgen levels(6 months)
  • Follicular number(6 months)
  • Gonadotrophins(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C.VOSNAKIS

Obstetrician- Gynecologist, Scientific Assosiate of Medical School of Aristotle University, Thessaloniki

Aristotle University Of Thessaloniki

研究点 (1)

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