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
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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2016
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedApril 20, 2017
April 1, 2017
3 months
April 10, 2017
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
Study Arms (2)
SITA
EXPERIMENTALSitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks
CON
EXPERIMENTALControls (CON) Lifestyle intervention
Interventions
Eligibility Criteria
You may qualify if:
- years old to menopause
- polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria)
- BMI of 30 kg/m2 or higher
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 20, 2017
Study Start
August 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
April 20, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share