Insulin Resistance, Polycystic Ovary Syndrome
Conditions
Brief summary
The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.
Interventions
DRUGIncresync
DRUGVipdomet
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR). | HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial. | HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5. |
| Primary outcome was change in beta cell function using adaptation index. | Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial. | Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator. |
| Primary outcome was change in fasting concentration of glucose. | Patient's fasting blood was drawn at the base point and at the endpoint of 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. |
| Primary outcome was change in fasting concentration of insulin. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome was change in body mass index (BMI). | Patient's body weight were measured at the base point 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. |
Countries
Slovenia
Outcome results
None listed