ObesityPhase 4NCT01475019
The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)
A Phase 4 study testing Orlistat, Sibutramine and Diet and physical exercise in people with Obesity and Polycystic Ovaries Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Obesity, Polycystic Ovaries Syndrome
- What is being tested?
- Orlistat, Sibutramine and Diet and physical exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2004to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal,
- nonpregnant,
- nonlactating,
- overweight and obese women
Who cannot join
- classical 21-hydroxylase deficiency,
- hyperprolactinemia,
- adrenal or ovarian tumor and Cushing's disease
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotle University of Thessaloniki Medical School
Thessaloniki, Thessaloniki, 54124
About this study
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
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).
Read the 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].
- Conditions
- Obesity, Polycystic Ovaries Syndrome
- Being tested
- Orlistat, Sibutramine, Diet and physical exercise
- Keywords
- Obesity, Polycystic Ovaries Syndrome, Orlistat, Sibutramine, Androgen levels, Insulin resistance
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrlistatDrug
Tablet, 120 mg, three times daily, for six months
SibutramineDrug
Tablet, 10 mg, once daily, for six months
Diet and physical exerciseBehavioural
Hypocaloric diet and regular physical exercise
| Study group | Role | What they receive |
|---|---|---|
| PCOS obese Orlistat | Experimental | Obese PCOS women treated with Orlistat, diet and physical exercise Receives: Drug: Orlistat |
| Obese Orlistat | Experimental | Obese women (non PCOS) treated with Orlistat, diet and physical exercise Receives: Drug: Orlistat |
| PCOS obese diet | Experimental | Obese PCOS women treated with diet and physical exercise Receives: Behavioral: Diet and physical exercise |
| PCOS obese Sibutramine | Experimental | Obese PCOS women treated with Sibutramine, diet and physical exercise Receives: Drug: Sibutramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti- Mullerian hormone (AMH) levels
Measured: 6 months
Secondary outcomes (4)
Weight loss
Measured: 6 months
Androgen levels
Free androgen index, Testosterone, 17OH Progesterone, D4 Andostenedione, Testosterone to Androstenedione ratio
Measured: 6 months
Follicular number
Mean follicular number
Measured: 6 months
Gonadotrophins
Follicular Stimulating Hormone (FSH), Luteneizing Hormone (LH), LH to FSH ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJan 2004
- Primary completionJan 2010
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.VOSNAKIS, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios Panidis, PhD, Study director, Aristotle University of Thessaloniki Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475019
- Sponsor's protocol ID
- A1732,2011
- Status last verified
- Nov 2011
- First submitted
- 14 Nov 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01475019
- Acronym / sponsor ID
- A1732,2011
- Conditions
- Obesity, Polycystic Ovaries Syndrome
- Keywords
- Obesity, Polycystic Ovaries Syndrome, Orlistat, Sibutramine, Androgen levels, Insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCOS obese Orlistat | Experimental | Drug: OrlistatObese PCOS women treated with Orlistat, diet and physical exercise |
| Obese Orlistat | Experimental | Drug: OrlistatObese women (non PCOS) treated with Orlistat, diet and physical exercise |
| PCOS obese diet | Experimental | Behavioral: Diet and physical exerciseObese PCOS women treated with diet and physical exercise |
| PCOS obese Sibutramine | Experimental | Drug: SibutramineObese PCOS women treated with Sibutramine, diet and physical exercise |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- premenopausal,
- nonpregnant,
- nonlactating,
- overweight and obese women
Key exclusion criteria (3 listed)
- classical 21-hydroxylase deficiency,
- hyperprolactinemia,
- adrenal or ovarian tumor and Cushing's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrlistatTablet, 120 mg, three times daily, for six months | Drug | Obese Orlistat, PCOS obese Orlistat |
| SibutramineTablet, 10 mg, once daily, for six months | Drug | PCOS obese Sibutramine |
| Diet and physical exerciseHypocaloric diet and regular physical exercise | Behavioural | PCOS obese diet |
Primary outcome
Anti- Mullerian hormone (AMH) levels
Time frame: 6 months
4 secondary outcomes
Weight loss
Time frame: 6 months
Androgen levels
Time frame: 6 months
Follicular number
Time frame: 6 months
Gonadotrophins
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Panidis, PhD study director
Aristotle University of Thessaloniki Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orlistat, Sibutramine and Diet and physical exercise in people with Obesity and Polycystic Ovaries Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti- Mullerian hormone (AMH) levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.