Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Participants received Sitagliptin 100 mg by mouth daily for up to 30 days.
Eligibility criteria:
Inclusion Criteria:

Females, age 18-40 years
BMI ≥ 30 kg/m2

Diagnosis of polycystic ovary syndrome defined by 2003 Rotterdam criteria as meeting two out of the three below criteria :

Oligomenorrhea or amenorrhea
clinical or biochemical evidence of hyperandrogenism (hirsutism and/or documented upper normal or elevated serum testosterone in the absence of exogenous hormone therapy or Metformin)
documented history of polycystic ovaries on ultrasound examination

Exclusion Criteria:

Smoking
Type 1 or Type 2 Diabetes Mellitus, as defined by a fasting glucose of 126 mg/dL or greater at the time of screening visit or the use of anti-diabetic medication
Hypertension, as defined by an untreated seated systolic blood pressure (SBP) greater than 150 mmHg and/or an untreated diastolic blood pressure (DBP) greater than 95 mmHg at the time of screening visit or the use of anti-hypertensive medication
History of reported or recorded hypoglycemia (plasma glucose < 70 mg/dL)
Pregnancy and/or Breast-Feeding (Negative serum pregnancy test will be confirmed at screening visit and every study visit.)
Surgical menopause, defined as s/p total hysterectomy including bilateral salpingo-oophorectomy
Use of transdermal or oral contraceptive therapy. The use of these contraceptives must be discontinued at least 8 weeks prior to study initiation.
The use of insulin sensitizers, specifically Metformin or thiazolidinediones must be discontinued 8 weeks prior to study initiation.
Anemia defined as hematocrit <35% at screening visit
Cardiovascular or cerebrovascular disease, including history of myocardial infarction, history of congestive heart failure, history of stroke
Pulmonary Hypertension
Abnormal thyroid hormone levels (TSH), prolactin, or morning 17 hydroxyprogesterone at the time of screening visit
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60
Impaired hepatic function (AST or ALT > 2 X upper limit of normal range)
Treatment with an investigational drug in the 1 month preceding the study
Allergy to any of the medications used in this protocol
Regular work of a night-shift or unusual schedule which may disrupt circadian rhythm.
Personal or Family History (defined as first degree relative) of Pancreatic Cancer
Personal history of Pancreatitis or known pancreatic lesions
Coagulopathy as defined by history
Regular NSAID use, including but not limited to, naproxen, ibuprofen, and aspirin
Mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Any underlying or acute disease requiring regular medication that could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult