NCT02811055

Pilot Study of Aprepitant Effect on Aldosterone Secretion in Diabetic Patient (Diabetes Mellitus) With Hypertension Associated With Low Renin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aldosterone regulation is mediated by hormonal control, and nervous control. Autonomic nervous system action could be mediated by neuropeptides in the adrenal gland. Therefore, in pathological conditions and especially in diabetes, low-renin hypertension with normal or high plasma aldosterone could be caused by sympathetic nervous system hypertonia. Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U982, University of Rouen) suggest that adrenal corticosteroid secretion might be controlled by sympathetic nervous system. This neurocrine regulation of corticosteroid secretion involves locally released neuropeptides. Among them, substance P is able to stimulate aldosterone and cortisol production via NK1 receptors. A previous clinical trial conducted at the University Hospital of Rouen, APHOS (NCT00977223) studied the effects of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in healthy volunteers. The aim of the present study is to investigate the effects of a NK1 receptor antagonist, aprepitant, on adrenocortical secretions in volunteers with diabetes associated with low-renin hypertension. Aprepitant is a drug already available for the treatment of nausea induced by chemotherapy. In the present phase II trial, plasma aldosterone and cortisol levels will be measured under treatment with aprepitant versus placebo, in both basal conditions and after activation of the adrenocortical function by upright posture. All volunteers will be given the two substances (aprepitant and placebo) in a random order during two 14 day-periods separated by a 21 day-wash-out. This study should allow to determine the role of substance P in the control of corticosteroid production in human with diabetes, associated with a low-renin hypertension.

Conditions

• Type 2 Diabetes
• Hypertension

Interventions

Type	Name	Description
BIOLOGICAL	Blood sampling	Blood sampling for Plasma aldosterone, Plasma cortisol, plasma renin, plasma electrolytes after before and after administration of Aprepitant 80 mg once per day during 14 days or Administration of placebo once per day during 14 days
PROCEDURE	Blood Pressure Measurement	Blood Pressure Measurement before and after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
DEVICE	electrocardiogram	Electrocardiogram before and after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
PROCEDURE	orthostatic test	Orthostatic test after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
DRUG	Administration of Aprepitant	Administration of Aprepitant 80 mg once per day during 14 days
DRUG	Administration of placebo	Administration of placebo once per day during 14 days

Timeline

• Start date: 2017-07-13
• Primary completion: 2020-12-05
• Completion: 2020-12-05
• First posted: 2016-06-23
• Last updated: 2026-03-24

Locations

1 site across 1 country: France