Back to results

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

Primary Purpose

PCOS

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sitagliptin

Lifestyle intervention

About this trial

This is an interventional prevention trial for PCOS focused on measuring metformin intolerance, PCOS, Sitagliptin, beta cell function

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SITA

CON

Arm Description

Sitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks

Controls (CON) Lifestyle intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03122041

First Posted

April 10, 2017

Last Updated

April 19, 2017

Sponsor

University Medical Centre Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT03122041

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PCOS

Keywords

metformin intolerance, PCOS, Sitagliptin, beta cell function

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SITA

Arm Type

Experimental

Arm Description

Sitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks

Arm Title

CON

Arm Type

Experimental

Arm Description

Controls (CON) Lifestyle intervention

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

Januvia

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle intervention

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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.

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs