Obesity, PCOS
Conditions
Keywords
PCOS, obesity, GLP-1 receptor agonist, liraglutide, metformin
Brief summary
The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with liraglutide or metformin.
Interventions
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 * poor response to previous treatment with metformin for at least 3 months
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 |
|---|---|
| The main outcome was change in body weight. | Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary outcome was change in body mass index (BMI). | Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint. | Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters. |
| The secondary outcome was change in waist circumference. | Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial. | Patient's waist circumference was measured in centimeters. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone). | Patient's fasting blood was drawn at the basepoint and every four weeks during the 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. |
| Other outcome was change in blood concentration of testosterone. | Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial. | Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L. |
| The other outcomes was changes changes in fasting concentrations of glucose. | Patient's fasting blood was drawn at the basepoint and every four weeks during the 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. |
| Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin). | Patient's fasting blood was drawn at the basepoint and every four weeks during the 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. |
| Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate). | Patient's fasting blood was drawn at the basepoint and every four weeks during the 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. |
| Other outcome was change in blood concentration in androstenedione. | Patient's fasting blood was drawn at the basepoint and every four weeks during the 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. |
| Other outcome was change in fasting concentration of insulin. | Patient's fasting blood was drawn at the basepoint and every four weeks during the 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. |
| Other outcome was change in blood concentrations of LH (luteinizing hormone). | Patient's fasting blood was drawn at the basepoint and every four weeks during the 12 weeks of clinical trial. | Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L. |
Countries
Slovenia
Outcome results
None listed