The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Obesity, Polycystic Ovaries Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Orlistat
Sibutramine
Diet and physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Polycystic Ovaries Syndrome, Orlistat, Sibutramine, Androgen levels, Insulin resistance
Eligibility Criteria
Inclusion Criteria:
- premenopausal,
- nonpregnant,
- nonlactating,
- overweight and obese women
Exclusion Criteria:
- classical 21-hydroxylase deficiency,
- hyperprolactinemia,
- adrenal or ovarian tumor and Cushing's disease
Sites / Locations
- Aristotle University of Thessaloniki Medical School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
PCOS obese Orlistat
Obese Orlistat
PCOS obese diet
PCOS obese Sibutramine
Arm Description
Obese PCOS women treated with Orlistat, diet and physical exercise
Obese women (non PCOS) treated with Orlistat, diet and physical exercise
Obese PCOS women treated with diet and physical exercise
Obese PCOS women treated with Sibutramine, diet and physical exercise
Outcomes
Primary Outcome Measures
Anti- Mullerian hormone (AMH) levels
Secondary Outcome Measures
Weight loss
Androgen levels
Free androgen index, Testosterone, 17OH Progesterone, D4 Andostenedione, Testosterone to Androstenedione ratio
Follicular number
Mean follicular number
Gonadotrophins
Follicular Stimulating Hormone (FSH), Luteneizing Hormone (LH), LH to FSH ratio
Full Information
NCT ID
NCT01475019
First Posted
November 14, 2011
Last Updated
November 18, 2011
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT01475019
Brief Title
The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)
Official Title
The Effect of Weight Loss With Orlistat or Sibutramine Administration , Hypocaloric Diet and Physical Exercise , on AMH Levels, in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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).
Outpatients, premenopausal, nonpregnant, nonlactating, overweight and obese women (body mass index, BMI >27), 18 years of age and older with PCOS were recruited for this study. The study included fifty seven (57) women with PCOS (mean age: 26.11±6.86 and mean body mass index: 34.83±6.39) who, besides diet and exercise, received Sibutramine treatment, matched for age and body mass index (BMI) with nineteen (19) obese women with PCOS (mean age: 26.95±4.77 and mean BMI: 36.79±6.98) treated only with diet and exercise. Diagnosis of PCOS was based on the 2003 Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus criteria . Women with no classical 21-hydroxylase deficiency, hyperprolactinemia, adrenal or ovarian tumor and Cushing's disease were excluded by the appropriate tests. Other exclusion criteria were hypertension, thyroid dysfunction, overt diabetes mellitus and concomitant treatment, such as antihypertensive drugs, selective serotonin reuptake inhibitor or other SNRI drug, oral contraceptive pills or any other antiandrogen treatment (cyproterone acetate, spirolactone, luteinizing hormone (LH) release hormone agonist) and insulin-sensitizing agents (metformin, pioglitazone, rosiglitazone) that may interact with insulin sensitivity and lipid profile.
Briefly, all patients were placed in a hypocaloric diet plus sibutramine (10mg per day) for the first month and then on a hypocaloric diet plus sibutramine (10mg per day) or hypocaloric diet only for the subsequent 6 months. A moderate physical activity (3 hours per week) 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.
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].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Polycystic Ovaries Syndrome
Keywords
Obesity, Polycystic Ovaries Syndrome, Orlistat, Sibutramine, Androgen levels, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCOS obese Orlistat
Arm Type
Experimental
Arm Description
Obese PCOS women treated with Orlistat, diet and physical exercise
Arm Title
Obese Orlistat
Arm Type
Experimental
Arm Description
Obese women (non PCOS) treated with Orlistat, diet and physical exercise
Arm Title
PCOS obese diet
Arm Type
Experimental
Arm Description
Obese PCOS women treated with diet and physical exercise
Arm Title
PCOS obese Sibutramine
Arm Type
Experimental
Arm Description
Obese PCOS women treated with Sibutramine, diet and physical exercise
Intervention Type
Drug
Intervention Name(s)
Orlistat
Intervention Description
Tablet, 120 mg, three times daily, for six months
Intervention Type
Drug
Intervention Name(s)
Sibutramine
Intervention Description
Tablet, 10 mg, once daily, for six months
Intervention Type
Behavioral
Intervention Name(s)
Diet and physical exercise
Intervention Description
Hypocaloric diet and regular physical exercise
Primary Outcome Measure Information:
Title
Anti- Mullerian hormone (AMH) levels
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
6 months
Title
Androgen levels
Description
Free androgen index, Testosterone, 17OH Progesterone, D4 Andostenedione, Testosterone to Androstenedione ratio
Time Frame
6 months
Title
Follicular number
Description
Mean follicular number
Time Frame
6 months
Title
Gonadotrophins
Description
Follicular Stimulating Hormone (FSH), Luteneizing Hormone (LH), LH to FSH ratio
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premenopausal,
nonpregnant,
nonlactating,
overweight and obese women
Exclusion Criteria:
classical 21-hydroxylase deficiency,
hyperprolactinemia,
adrenal or ovarian tumor and Cushing's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Panidis, PhD
Organizational Affiliation
Aristotle University of Thessaloniki Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Aristotle University of Thessaloniki Medical School
City
Thessaloniki
ZIP/Postal Code
54124
Country
Greece
12. IPD Sharing Statement
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The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)
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