Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome

Phase 4CompletedNCT03122041

University Medical Centre Ljubljana30 enrolled

Overview

Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

PCOS

Interventions

SitagliptinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old to menopause * polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria) * BMI of 30 kg/m2 or higher Exclusion Criteria: * significant cardiovascular disease * significant kidney or hepatic disease * personal or family history of medullary thyroid carcinoma * known history of gallbladder disease * known history of pancreatitis

Outcomes

Primary Outcomes

The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index).

Time frame: Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial.

Secondary Outcomes

The secondary outcome was change in fasting plasma glucose level (G0)

Time frame: Patient's fasting glucose level was measured at the base point and after 12 weeks of clinical trial.

The secondary outcome was change in plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT).

Time frame: Patient's plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT) was measured at the base point and after 12 weeks of clinical trial.