Effect of DPP4 Inhibition on Growth Hormone Secretion

Completed · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT01701973

Run by

Vanderbilt University

People needed

44

Starts

2013-01-01

Expected to finish

2017-05-01

Last updated by the study team

2018-05-29

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 < 70 mg/dL)
• Pregnancy and/or Breast-Feeding
• Use of any medication other than multivitamin, including use of transdermal as well as oral hormone replacement therapy or use of oral contraceptive therapy
• 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) at the time of screening visit
• Abnormal serum insulin like growth factor-1 (IGF-1) at the time of screening visit
• Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m\^2
• Impaired hepatic function (alanine or aspartate transaminase > 2 X upper limit of normal range)
• Treatment with an investigational drug in the 1 month preceding the study

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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