Pilot study of aprepitant effect on aldosterone secretion in diabetic patient with hypertension associated with low reni

Phase 1

• Conditions: Diabetic patient (diabetes mellitus) with hypertension associated with low renin; MedDRA version: 18.1Level: HLTClassification code 10052741Term: Endocrine and metabolic secondary hypertensionSystem Organ Class: 100000004866; MedDRA version: 18.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001501-14-FR
• Lead Sponsor: Rouen University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-29
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or menopausal female subjects;
• Age ranging 18-30 years old;
• Submitted to a social security regimen;
• Agreeing to the study & Informed consent form signed;
• Body mass index ([weight (kg)/height (m)]²) < 27;
• No treatment received 6 weeks before inclusion;
• No anomaly after: complete clinical examination, pulse and blood pressure measurement, ECG;
• No biological abnormality after the following biological testing:
• Hematology: white & red blood cells & platelets count, haemoglobin, hematocrit,
• Blood biochemistry: sodium, potassium, chloride, bicarbonate, creatinine, urea,
• Urinary biochemistry (24 h collection): cortisol, aldosterone,
• Serologies: HIV, HBV, HCV,
• No participation in a clinical trial 3 months ago before inclusion,
• Subscription to national social security,
• Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• Female subject potentially pregnant,
• Subject younger than 18 year-old and older than 70 year-old,
• Subject without diabetes condition or with diabetes but normal blood pressure (below 130/80 mmHg),
• Subject with glycated hemoglobin HbA1c < 6.5% or >11%,
• Subject with leuconeutropenia (neutrophils below 1700/mm3),
• Subject with severe medical or surgical history,
• Patients treated with drugs metabolized by CYP3A4 and CYP2C9: corticosteroids, vitamin K , hormonal contraceptives, tolbutamide, benzodiazepines, derived from ergot, antiepileptics, hypericum, macrolides, azole antifungals.
• Patients treated with drugs interfering with the renin-angiotensin- aldosterone system : beta-blockers, diuretics , anti -aldosterone drugs , direct renin inhibitors , insulin,
• type 2 diabetes patients with a vegetative autonomic neuropathy,
• Patients with adrenal mass was diagnosed at imaging,
• hepatic or renal impairment (defined respectively by secondary clinical and biological manifestations altered hepatocyte functions or estimated glomerular filtration rate less than 60 mL / min / 1.73 m2);nephrotic syndrome (defined by hypoalbuminemia less than 30 g / L associated with proteinuria at 3 grams / 24 hours);edematous syndrome (defined by the presence of edema of the lower limbs),
• Orthostatic hypotension (defined by a decrease in systolic blood pressure of 20 mmHg and at least the diastolic blood pressure of 10 mmHg or more),
• arrhythmias or cardiac conduction,
• heart failure (NYHA class II minimum),
• epilepsy,
• serious psychiatric condition,
• Severe allergic history, hypersensitivity to aprepitant,
• People with hereditary problems of fructose intolerance, glucose malabsorption, galactose, or sucrase-isomaltase,
• People with lactose intolerance,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified