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NCT01701973 · ClinicalTrials.gov registry record · Phase 4
Effect of DPP4 Inhibition on Growth Hormone Secretion
A Phase 4 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT01701973: Completed Phase 4 study, sponsored by Vanderbilt University.
NCT01701973 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701973, a Phase 4 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study 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.
Primary Outcome
Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
Interventions
- DRUG Placebo
- DRUG Sitagliptin
- DRUG L-NMMA
- DRUG Pegvisomant
- DRUG Exendin 9-39
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-05 |
| Phase | Phase 4 |
What the finished NCT01701973 record still lists
NCT01701973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01701973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701973 about?
NCT01701973 is a clinical study titled "Effect of DPP4 Inhibition on Growth Hormone Secretion". 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 grow...
What is the current status of trial NCT01701973?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2013-01. Estimated completion is 2017-05.
What interventions are being tested in trial NCT01701973?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG), L-NMMA (DRUG), Pegvisomant (DRUG), Exendin 9-39 (DRUG).
Who is sponsoring clinical trial NCT01701973?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701973's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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