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

Study Overview
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Brief Summary
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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.

Official Title
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Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance IGT and Type 2 Diabetes T2D in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome PCOS

Conditions
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PCOS

Intervention / Treatment
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* Drug: Sitagliptin
* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SITA<br>Sitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks | Drug: Sitagliptin<br> <br> * Other names: Januvia;Behavioral: Lifestyle intervention<br> <br> |
| Experimental: CON<br>Controls (CON) Lifestyle intervention | Behavioral: Lifestyle intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index). |  | Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome was change in fasting plasma glucose level (G0) |  | 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). |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, metformin intolerance, Sitagliptin, beta cell function