Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS

University Medical Centre Ljubljana30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome Insulin Resistance

Interventions

VipdometDRUG

IncresyncDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).

HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.

Time frame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.

Primary outcome was change in beta cell function using adaptation index.

Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.

Time frame: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.

Primary outcome was change in fasting concentration of glucose.

Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

Time frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Primary outcome was change in fasting concentration of insulin.

Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.

Time frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Secondary Outcomes

Secondary outcome was change in body mass index (BMI).

Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

Time frame: 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

Data from ClinicalTrials.gov

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