Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01475019
Status:
UNKNOWN
Last Update Posted:
2011-11-21
First Post:
2011-11-14
Brief Title:
The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome PCOS
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2011-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The first aim of the investigators study was to investigate the combined effect of dietphysical 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 dietphysical exercise plus sibutramine on serum AMH levels body composition hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome PCOS
The other aim of the investigators study was to examine the effect of hypocaloric dietphysical 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 dietphysical 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 2611686 and mean body mass index 3483639 matched for age and body mass index BMI with twenty 20 obese women without PCOS mean age 2695477 and mean BMI 3679698 Diagnosis of PCOS was based on the 2003 Rotterdam ESHREASRM-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 kcald for a period of 24 weeks In addition orlistat Xenical Roche SA Greece 120 mg 3 times per day was administered before each meal for 24 weeks At baseline week 12 and week 24 at 900 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 SubstanceAMH enzyme-linked immunosorbent assay ELISA kit DSL Laboratories Webster TX The theoretical sensitivity of the method is 0006 ngml the intra-assay coefficient of variation for high values is 33 and the interassay coefficient of variation for high values is 67
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 ovary2 and mean ovarian volume expressed as the mean volume of both ovaries volume of right ovary volume of left ovary2
The other aim of our study was to examine the effect of hypocaloric dietphysical 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 2611686 and mean body mass index 3483639 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 2695477 and mean BMI 3679698 treated only with diet and exercise Diagnosis of PCOS was based on the 2003 Rotterdam ESHREASRM-Sponsored PCOS Consensus criteria Women with no classical 21-hydroxylase deficiency hyperprolactinemia adrenal or ovarian tumor and Cushings 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 kcald for a period of 24 weeks
At baseline week 12 and week 24 at 900 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 SubstanceAMH enzyme-linked immunosorbent assay ELISA kit DSL Laboratories Webster TX
The study included sixty one 61 women with PCOS mean age 2611686 and mean body mass index 3483639 matched for age and body mass index BMI with twenty 20 obese women without PCOS mean age 2695477 and mean BMI 3679698 Diagnosis of PCOS was based on the 2003 Rotterdam ESHREASRM-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 kcald for a period of 24 weeks In addition orlistat Xenical Roche SA Greece 120 mg 3 times per day was administered before each meal for 24 weeks At baseline week 12 and week 24 at 900 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 SubstanceAMH enzyme-linked immunosorbent assay ELISA kit DSL Laboratories Webster TX The theoretical sensitivity of the method is 0006 ngml the intra-assay coefficient of variation for high values is 33 and the interassay coefficient of variation for high values is 67
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 ovary2 and mean ovarian volume expressed as the mean volume of both ovaries volume of right ovary volume of left ovary2
The other aim of our study was to examine the effect of hypocaloric dietphysical 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 2611686 and mean body mass index 3483639 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 2695477 and mean BMI 3679698 treated only with diet and exercise Diagnosis of PCOS was based on the 2003 Rotterdam ESHREASRM-Sponsored PCOS Consensus criteria Women with no classical 21-hydroxylase deficiency hyperprolactinemia adrenal or ovarian tumor and Cushings 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 kcald for a period of 24 weeks
At baseline week 12 and week 24 at 900 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 SubstanceAMH enzyme-linked immunosorbent assay ELISA kit DSL Laboratories Webster TX
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None