Phase 4
N=23
The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02122380 ↗Enrolled (actual)
23
Serious AEs
2.4%
Results posted
May 2020
Primary outcome: Primary: Mean Overnight Growth Hormone Levels — 0.85; 0.84 ng/mL — p=0.918
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overnight Growth Hormone Levels |
0.85; 0.84 | 0.918 |
| SECONDARY Early Insulin Secretion During Oral Glucose Tolerance Test |
1522.1; 1871.3 | 0.054 |
| SECONDARY Area Under the Curve (AUC) for Blood Glucoses During 75 Gram Oral Glucose Tolerance Test |
15353.8; 13877.5 | 0.009 sig |
| SECONDARY Visceral Adipose Tissue |
1141.9; 1055.1 | 0.022 sig |
| SECONDARY Vascular Function (Endothelium-dependent Vasodilation) |
13.63; 13.00 | 0.943 |
Summary
Adults with abdominal obesity are at high risk for cardiovascular disease and also exhibit diminished growth hormone (GH) secretion; the latter further contributes to the development of visceral adiposity, impaired fibrinolysis and inflammation.Growth hormone releasing hormone (GHRH), the primary stimulus for endogenous GH secretion, is a substrate of dipeptidyl peptidase 4 (DPP4); inhibition of DPP4 with the currently available anti-diabetic therapy, sitagliptin, may therefore increase GH secretion by decreasing the degradation of GHRH. The proposed research will test the hypothesis that chronic sitagliptin therapy will enhance GH secretion and vascular function while improving glucose tolerance in patients with impaired GH secretion who are at risk for the development of diabetes mellitus and cardiovascular disease, specifically obese women with polycystic ovary syndrome.
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 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
Data sourced from ClinicalTrials.gov (NCT02122380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.