Phase 4
N=44
Effect of DPP4 Inhibition on Growth Hormone Secretion
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01701973 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Aim 1: Stimulated Peak Growth Hormone Level — 5.2; 3.1; 1.9; 2.0 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug); Pegvisomant (Drug); Placebo (Drug); L-NMMA (Drug); Exendin 9-39 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aim 1: Stimulated Peak Growth Hormone Level |
5.2; 3.1; 1.9; 2.0; 9.5; 6.6 | — |
| PRIMARY Aim 1: Percent Change From Baseline in Forearm Vascular Resistance |
-5.0677; -5.3498; 1.4929; -11.2235; -5.1365; -1.0195 | — |
| PRIMARY Aim 1: Percent Change From Baseline in Forearm Blood Flow |
0.4835; 1.6458; -.0238; 9.2597; 5.3416; 4.9101 | — |
| PRIMARY Aim 2: Percent Change From Baseline in Forearm Blood Flow |
-0.71; -9.34; 5.17; 14.78; 15.64; 0.39 | — |
| PRIMARY Aim 2: Percent Change From Baseline in Forearm Vascular Resistance |
-8.67; 8.98; -9.87; -14.60; -20.00; -3.75 | — |
| SECONDARY Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels |
0.30; 0.28; 0.44; 0.22; 0.40; 0.32 | — |
| SECONDARY Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels |
0.24; 0.10; 0.26; 0.15; 0.33; 0.17 | — |
| SECONDARY Aim 2: Measurement of Growth Hormone (GH) Levels |
2.99; 4.27; 5.92; 7.00; 6.05; 11.53 | — |
Summary
This study tests the following hypotheses:
Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone releasing hormone (GHRH).
Aim 2: Test the hypothesis that decreased degradation of GHRH during acute DPP4 inhibition will result in an increase in endothelium-dependent vasodilation mediated by GH and independent from GLP1 (glucagon like peptide-1) in healthy lean adults.
This study promises to provide novel data regarding how this increasingly used class of anti-diabetic drugs affects the pituitary GH axis and could affect blood vessel relaxation. Growth hormone levels are low in the setting of obesity and pre-diabetes. A further study may evaluate the effect of chronic DPP4 inhibitor therapy in a population of patients with obesity and pre-diabetes.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 40 years inclusive
- BMI ≤ 25 kg/m2
- For female subjects:
Status-post surgical sterilization, or If of child-bearing potential, utilization of a barrier method of birth control following negative serum pregnancy test at screening visit and on every study day
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 140 mmHg and/or an untreated diastolic blood pressure (DBP) greater than 90 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
Data sourced from ClinicalTrials.gov (NCT01701973). 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.