Obesity, PCOS
Conditions
Keywords
response to therapy
Brief summary
The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.
Interventions
DRUGMetformin
DRUGGlucophage tablets and Victoza
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old to menopause * polycystic ovary syndrome (NICHD criteria) * BMI of 30 kg/m² or higher
Exclusion criteria
* type 1 or type 2 diabetes mellitus * history of carcinoma * Cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of MEN 2 * significant cardiovascular, kidney or hepatic disease * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight | up to 12 weeks of clinical trial |
| The number of good responders to combined treatment regarding body weight | up to 12 weeks of clinical trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index (BMI). | up to 12 weeks of clinical trial | Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters. |
| Change in waist circumference | up to 12 weeks of clinical trial | waist circumference was measured in centimeters. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in blood concentration of testosterone | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L. |
| Change in blood concentration in androstenedione | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L. |
| Change in fasting concentrations of glucose | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. |
| Change in blood concentration of DHEAS (dehydroepiandrosterone sulfate) | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L. |
| Change in blood concentrations of SHBG (sex hormone-binding globulin) | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L. |
| Change in fasting concentration of insulin | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L. |
| Change in blood concentrations of LH (luteinizing hormone) | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L. |
| Change in blood concentrations of FSH (follicle-stimulating hormone) | up to 12 weeks of clinical trial | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L. |
Countries
Slovenia
Outcome results
None listed