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

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122041
• Other study ID #: Metformin Intolerant PCOS
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2017
• Last updated: April 19, 2017
• Start date: August 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PCOS
• Polycystic Ovary Syndrome

Intervention

Drug:
• Sitagliptin

Behavioral:
• Lifestyle intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome was change in HOMA-ß index (Homeostasis model assessment for beta cell function index).		Homeostasis model assessment for beta cell function index (HOMA-ß) was calculated at the base point and after 12 weeks of clinical trial.
Secondary	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.
Secondary	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.