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

NCT ID: NCT03122041

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-11-30

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.

Detailed Description

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Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SITA

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

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

Lifestyle intervention

Intervention Type BEHAVIORAL

CON

Controls (CON) Lifestyle intervention

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Interventions

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Sitagliptin

Intervention Type DRUG

Lifestyle intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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Januvia

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Simona Ferjan, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Metformin Intolerant PCOS

Identifier Type: -

Identifier Source: org_study_id

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