Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Orlistat, Lifestyle Intervention, Quality of Life
Brief summary
This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age and is frequently associated with obesity, insulin resistance, dyslipidemia, and hormonal imbalance. Lifestyle modification remains the cornerstone of management; however, additional therapeutic options are needed to improve metabolic and reproductive outcomes. Orlistat, a gastrointestinal lipase inhibitor, promotes weight reduction by decreasing dietary fat absorption and has demonstrated potential benefits in improving insulin resistance and lipid metabolism. This study is a single-center, randomized controlled clinical trial to be conducted at Ayub Teaching Hospital, Abbottabad. A total of 120 women aged 18-45 years with PCOS diagnosed according to the Rotterdam criteria will be enrolled and randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive orlistat capsules twice daily in addition to standard lifestyle advice, while participants in the control group will receive placebo together with the same lifestyle recommendations, including a healthy diet and regular physical activity. The intervention period will last three months. Participants will undergo baseline assessment, telephone follow-up visits at one and two months to monitor treatment adherence, and a final in-person assessment after three months. The primary outcome is improvement in at least one abnormality defined by the Rotterdam diagnostic criteria. Secondary outcomes include changes in sex hormone profile (LH, FSH, LH/FSH ratio, AMH, and free testosterone), fasting glucose and insulin parameters, HbA1c, lipid profile, liver function tests, lipid accumulation product, hepatic steatosis index, ultrasound grading of non-alcoholic fatty liver disease, anthropometric measures, and PCOS-related quality of life. The findings of this study will provide evidence regarding the effectiveness of orlistat as an adjunct to lifestyle modification for improving the metabolic and hormonal manifestations of PCOS in women.
Interventions
DRUGOrlistat
Oral Orlistat capsules administered twice daily between lunch and dinner for 3 months as an adjunct to the recommended care plan for women with polycystic ovary syndrome (PCOS). Participants will also receive standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling.
DRUGPlacebo
Matching placebo capsules administered twice daily for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling, for women with polycystic ovary syndrome (PCOS).
BEHAVIORALStandard Lifestyle Advice
Participants will receive standardized lifestyle advice, including maintaining a healthy diet, engaging in regular physical activity, and performing at least 30 minutes of walking or cycling daily throughout the 3-month study period.
Sponsors
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants will be blinded to treatment allocation. Participants in the intervention and control groups will receive identical-appearing capsules (Orlistat or placebo). Care providers, investigators, and outcome assessors will not be blinded to group assignment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups using simple randomization. The intervention group will receive orlistat in addition to standard lifestyle advice, while the control group will receive placebo plus the same standard lifestyle advice for three months. Participants will remain in their assigned group throughout the study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Females aged 18-45 years. * Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following): * Oligomenorrhea or amenorrhea. * Clinical or biochemical hyperandrogenism. * Polycystic ovaries on ultrasonography. * Body mass index (BMI) between 18.5 and 35 kg/m² (Asian criteria).
Exclusion criteria
* Current or recent use of oral contraceptives, ovulation induction medications, anti-obesity medications, cholesterol-lowering medications, or other therapies/supplements known to affect insulin physiology or androgen metabolism (e.g., inositols, curcumin, lipoic acid, cinnamon, gymnemic, or other botanical extracts). * Women undergoing in vitro fertilization (IVF) treatment. * Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus. * Presence of severe renal or liver disease. * Menopausal, pregnant, or breastfeeding women. * Anti-Müllerian Hormone (AMH) \< 0.7 ng/mL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polycystic Ovary Syndrome (PCOS) Features | Baseline and 3 months | Improvement in at least one baseline abnormality according to the Rotterdam Criteria, including ovulatory dysfunction, hyperandrogenism, or polycystic ovarian morphology on ultrasonography. |
| Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) Ratio | Baseline and 3 months | Change in serum LH/FSH ratio measured by laboratory assay. Higher values indicate greater hormonal imbalance. |
| Anti-Müllerian Hormone (AMH) | Baseline and 3 months | Change in serum Anti-Müllerian Hormone concentration (ng/mL) measured by laboratory assay. |
| Follicle Stimulating Hormone (FSH) | Baseline and 3 months | Change in serum FSH concentration (IU/L) measured by laboratory assay |
| Luteinizing Hormone (LH) | Baseline and 3 months | Change in serum LH concentration (IU/L) measured by laboratory assay. |
| Free Testosterone | Baseline and 3 months | Change in serum free testosterone concentration measured by laboratory assay. |
| Fasting Blood Glucose | Baseline and 3 months | Change in fasting blood glucose concentration (mg/dL) measured by laboratory assay. |
Countries
Pakistan
Contacts
CONTACTProf Dr Ruqqiya Sultana, MBBS
CONTACTDr Noman Arif, PhD
PRINCIPAL_INVESTIGATORProf Dr Ruqqiya Sultana, MBBS
Khyber Medical Univeristy Peshawar
PRINCIPAL_INVESTIGATORDr Noman Arif, PhD
Khyber Medical Univeristy Peshawar
Outcome results
None listed