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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

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ClinicalTrials.gov Identifier: NCT03122041
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Simona Ferjan, MD, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
PCOS Drug: Sitagliptin Behavioral: Lifestyle intervention Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: SITA
Sitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks
Drug: Sitagliptin
Other Name: Januvia

Behavioral: Lifestyle intervention
Experimental: CON
Controls (CON) Lifestyle intervention
Behavioral: Lifestyle intervention



Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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. ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Simona Ferjan, MD, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03122041     History of Changes
Other Study ID Numbers: Metformin Intolerant PCOS
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simona Ferjan, MD, University Medical Centre Ljubljana:
metformin intolerance
PCOS
Sitagliptin
beta cell function
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Glucose Intolerance
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action