Type 2 DiabetesPhase 2APHOS-02NCT02811055
Pilot Study of Aprepitant Effect on Aldosterone Secretion in Diabetic Patient (Diabetes Mellitus) With Hypertension Associated With Low Renin
A Phase 2 study testing Blood sampling, Blood Pressure Measurement and electrocardiogram in people with Type 2 Diabetes and Hypertension, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hypertension
- What is being tested?
- Blood sampling, Blood Pressure Measurement and electrocardiogram
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2017to 5 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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,
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- 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,
- subject unwilling or cannot be followed regularly. Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent and those admitted to a health or social establishment for purposes other than research, the adults subject to a measure of legal protection or unable to consent may not be included.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Blood sampling, Blood Pressure Measurement, electrocardiogram, orthostatic test, Administration of Aprepitant
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
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
Blood Pressure MeasurementProcedure or surgery
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
electrocardiogramDevice
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
orthostatic testProcedure or surgery
Orthostatic test after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
Administration of AprepitantDrug
Administration of Aprepitant 80 mg once per day during 14 days
Administration of placeboDrug
Administration of placebo once per day during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Administration of Aprepitant | Experimental | Administration of Aprepitant 80 mg once per day during 14 days; Blood sampling, electrocardiogram, orthostatic test and Blood Pressure Measurement are done after 14 days Receives: Biological: Blood sampling; Procedure: Blood Pressure Measurement; Device: electrocardiogram; Procedure: orthostatic test; Drug: Administration of Aprepitant |
| Administration of placebo | Placebo comparator | Administration of Placebo once per day during 14 days; Blood sampling, electrocardiogram, orthostatic test and Blood Pressure Measurement are done after 14 days Receives: Biological: Blood sampling; Procedure: Blood Pressure Measurement; Device: electrocardiogram; Procedure: orthostatic test; Drug: Administration of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline in Plasma aldosterone concentration
Plasma aldosterone concentration is analyzed
Measured: Baseline and Day 14
Secondary outcomes (4)
Difference from baseline in Plasma cortisol
Plasma cortisol concentration is analyzed
Measured: Baseline and Day 14
Difference from baseline in plasma renin
plasma renin concentration is analyzed
Measured: Baseline and Day 14
Difference from baseline in blood electrolytes measurement
blood electrolytes concentration is analyzed
Measured: Baseline and Day 14
Difference from baseline in HOMA index
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start13 Jul 2017
- Primary completion5 Dec 2020
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaétan PREVOST, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811055
- Sponsor's protocol ID
- 2013/142/HP
- Other IDs
- 2015-001501-14, 2015
- Acronym
- APHOS-02
- Status last verified
- Mar 2026
- First submitted
- 25 May 2016
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Aprepitant Effect on Aldosterone Secretion in Diabetic Patient (Diabetes Mellitus) With Hypertension Associated With Low Renin
- ClinicalTrials.gov ID
- NCT02811055
- Acronym / sponsor ID
- APHOS-02 / 2013/142/HP
- Conditions
- Type 2 Diabetes, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 5 Dec 2020 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Aprepitant | Experimental | Biological: Blood sampling, Procedure: Blood Pressure Measurement, Device: electrocardiogram, Procedure: orthostatic test, Drug: Administration of AprepitantAdministration of Aprepitant 80 mg once per day during 14 days; Blood sampling, electrocardiogram, orthostatic test and Blood Pressure Measurement are done after 14 days |
| Administration of placebo | Placebo comparator | Biological: Blood sampling, Procedure: Blood Pressure Measurement, Device: electrocardiogram, Procedure: orthostatic test, Drug: Administration of placeboAdministration of Placebo once per day during 14 days; Blood sampling, electrocardiogram, orthostatic test and Blood Pressure Measurement are done after 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (20 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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 | Biological | Administration of Aprepitant, Administration of placebo |
| Blood Pressure MeasurementBlood 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 | Procedure or surgery | Administration of Aprepitant, Administration of placebo |
| electrocardiogramElectrocardiogram 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 | Administration of Aprepitant, Administration of placebo |
| orthostatic testOrthostatic test after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days | Procedure or surgery | Administration of Aprepitant, Administration of placebo |
| Administration of AprepitantAdministration of Aprepitant 80 mg once per day during 14 days | Drug | Administration of Aprepitant |
| Administration of placeboAdministration of placebo once per day during 14 days | Drug | Administration of placebo |
Primary outcome
Difference from baseline in Plasma aldosterone concentration
Time frame: Baseline and Day 14
Plasma aldosterone concentration is analyzed
4 secondary outcomes
Difference from baseline in Plasma cortisol
Time frame: Baseline and Day 14
Difference from baseline in plasma renin
Time frame: Baseline and Day 14
Difference from baseline in blood electrolytes measurement
Time frame: Baseline and Day 14
Difference from baseline in HOMA index
Time frame: Baseline and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaétan PREVOST, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blood sampling, Blood Pressure Measurement and electrocardiogram in people with Type 2 Diabetes and Hypertension, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference from baseline in Plasma aldosterone concentration (time frame: Baseline and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.