Type 2 Diabetes MellitusNCT02130687

Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure

A study testing Sitagliptin, Aprepitant and Mixed Meal Test (MMT) in people with Type 2 Diabetes Mellitus and Hypertension, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study the investigators will test the hypothesis that dipeptidyl peptidase IV (DPP4) inhibition attenuates the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibition but not angiotensin receptor blockade or calcium channel blockade. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Type 2 Diabetes Mellitus, Hypertension
What is being tested?: Sitagliptin, Aprepitant and Mixed Meal Test (MMT)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 80 years old
For female subjects the following conditions must be met:
Postmenopausal status for at least 1 year, or Status-post surgical sterilization, or If of childbearing potential, utilization of barrier methods of birth control and willingness to undergo urine β-HCG testing prior to drug treatment and on every study day
T2DM, as defined by 1 or more of the following at the time of screening visit:
Hgb A1C ≥6.5%, or
Fasting plasma glucose ≥126mg/dL, or

Show all 11Show fewer

2-hour plasma glucose ≥200 mg/dL following 75gr oral glucose load
Hypertension, as defined by:
Seated SBP ≥130 mm Hg on three occasions documented in medical record, or
Seated DBP ≥80 mm Hg on three occasions documented in medical record, or
Treatment with antihypertensive medications for a minimum of 6 months

Who cannot join

Type 1 diabetes
Poorly controlled T2DM, defined as Hgb A1C>8.7%
Use of anti-diabetic medications other than metformin for at least 12 months prior to initiation of the study
Secondary hypertension
Subjects who have participated in a weight-reduction program during the last 6 months and whose weight has increased or decreased more than 5 kg over the preceding 6 months
Pregnancy

Show all 24Show fewer

Breast-feeding
Treatment with drugs primarily metabolized through CYP3A4 (e.g. cisapride, pimozide)
Clinically significant gastrointestinal impairment that could interfere with drug absorption
Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy and diastolic dysfunction acceptable), deep vein thrombosis, pulmonary embolism, second- or third-degree AV block, mitral valve stenosis, or hypertrophic cardiomyopathy
Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >3 x upper limit of normal range)
Impaired renal function (eGFR< 50mL/min/1.73m2 as determined by the MDRD equation)
History or presence of immunological or hematological disorders.
History of pancreatitis or know pancreatic lesion
History of angioedema while taking an ACE inhibitor
Hematocrit <35%
Treatment with anticoagulants
Diagnosis of asthma requiring use of inhaled β-2 agonist more than 1 time per week
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
Treatment with systemic glucocorticoids within the last 6 months
Treatment with lithium salts
Treatment with any investigational drug in the 1 month preceding the study
Mental conditions rendering the subject unable to understand the nature, scope, or possible consequences of the study
Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Contribution of Substance P to Blood Pressure Regulation in the Setting of Dipeptidyl Peptidase IV (DPP4) and Angiotensin-Converting Enzyme (ACE) Inhibition

Read the detailed description

The use of dipeptidyl peptidase IV (DPP4) inhibitors for the treatment of type 2 diabetes (T2DM) is growing rapidly. The majority of patients with T2DM are also taking ACE inhibitors or angiotensin receptor blockers (ARBs) in order to reduce cardiovascular and renal morbidity and mortality. DPP4 and ACE inhibitors share the common vasoactive substrate substance P. Substance P acts as a vasodilator but also activates the sympathetic nervous system. Understanding the interactive effects of DPP4 and ACE inhibitors on blood pressure and neurohumoral activation has important implications for the millions of patients with T2DM who take these drugs concurrently.

Conditions: Type 2 Diabetes Mellitus, Hypertension
Being tested: Placebo, Sitagliptin, Aprepitant, Mixed Meal Test (MMT)
Keywords: Type 2 Diabetes Mellitus, Hypertension, Angiotensin Converting Enzyme Inhibitors, Dipeptidyl Peptidase IV Inhibitors, Sitagliptin, Aprepitant, Ramipril
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.

PlaceboDrug
Also called Microcrystalline cellulose
Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
SitagliptinDrug
Also called Januvia
Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
AprepitantDrug
Also called Emend
Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT)Other
The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.

Study groups in NCT02130687
Study group	Role	What they receive
Amlodipine	Active comparator	Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant. Receives: Drug: Placebo; Drug: Sitagliptin; Drug: Aprepitant; Other: Mixed Meal Test (MMT)
Ramipril	Experimental	Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant. Receives: Drug: Placebo; Drug: Sitagliptin; Drug: Aprepitant; Other: Mixed Meal Test (MMT)
Valsartan	Active comparator	Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant. Receives: Drug: Placebo; Drug: Sitagliptin; Drug: Aprepitant; Other: Mixed Meal Test (MMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Arterial Blood Pressure
The primary analyses will focus on mean arterial blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Measured: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
Heart Rate
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Measured: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
Norepinephrine (NE) Concentrations
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Measured: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)

Secondary outcomes (9)

Low Frequency Variability of Blood Pressure Activity
Low frequency variability of systolic blood pressure will be measured using spectral analysis.
Measured: for 5 minutes on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Glucose
measure of effectiveness of DPP4 inhibitor
Measured: fasting at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Insulin
Measure of insulin resistance.
Measured: fasting insulin measured at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitatliptin+aprepitant)
Dipeptidyl Peptidase IV (DPP4) Activity
Measure of DPP4 inhibitor administration.
Measured: for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Angiotensin Converting Enzyme (ACE) Activity
This is a measure of activity of the angiotensin-converting enzyme (ACE). The assay is a kinetic assay (Labcore) that measures the rate of cleavage of an added ACE substrate over time and the results are reported in Units, which represent the rate of increase in fluorescent metabolite over 30 minutes under standard conditions at 37C.
Measured: for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Mean Arterial Blood Pressure
Average of measurements made every five minutes beginning just prior to (time 0) and for four hours after the ingestion of a mixed meal
Measured: Value provided is the AVERAGE of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
Heart Rate
The average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal
Measured: Value provided is the average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
Neuropeptide Y
Measurement of Neuropeptide Y (NPY) concentrations
Measured: Neuropeptide Y concentration prior to ingestion of the mixed meal.
24hr Urinary Testing for Sodium
Subjects will collect 24hr urine sample and bring with to the study day for analysis
Measured: Urine was collected for sodium for 24 hrs prior to each of the study days listed below. Study days occurred after each 7-day treatment arm (placebo/placebo, sitagliptin/placebo, or sitagliptin/aprepitant) within 3 anti-hypertensive groups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Aug 2020

First posted5 May 2014 (estimated)
Study startJun 2014
Primary completionMay 2020
Study completionAug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02130687
Sponsor's protocol ID: 121253
Status last verified: Feb 2022
First submitted: 30 Apr 2014
Last updated: 2 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mashayekhi M, Wilson JR, Jafarian-Kerman S, Nian H, Yu C, Shuey MM, Luther JM, Brown NJ. Association of a glucagon-like peptide-1 receptor gene variant with glucose response to a mixed meal. Diabetes Obes Metab. 2021 Jan;23(1):281-286. doi: 10.1111/dom.14216. Epub 2020 Oct 22.
PubMed 33001556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contribution of Substance P to Blood Pressure Regulation in the Setting of Dipeptidyl Peptidase IV (DPP4) and Angiotensin-Converting Enzyme (ACE) Inhibition
ClinicalTrials.gov ID: NCT02130687
Acronym / sponsor ID: 121253
Conditions: Type 2 Diabetes Mellitus, Hypertension
Keywords: Type 2 Diabetes Mellitus, Hypertension, Angiotensin Converting Enzyme Inhibitors, Dipeptidyl Peptidase IV Inhibitors, Sitagliptin, Aprepitant, Ramipril
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Study start: Jun 2014
Primary completion: May 2020 (actual)
Study completion: Aug 2020 (actual)
First posted: 5 May 2014 (estimated)
Results: Posted 26 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Amlodipine	Active comparator	Drug: Placebo, Drug: Sitagliptin, Drug: Aprepitant, Other: Mixed Meal Test (MMT)Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Ramipril	Experimental	Drug: Placebo, Drug: Sitagliptin, Drug: Aprepitant, Other: Mixed Meal Test (MMT)Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Valsartan	Active comparator	Drug: Placebo, Drug: Sitagliptin, Drug: Aprepitant, Other: Mixed Meal Test (MMT)Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age 18 to 80 years old
Postmenopausal status for at least 1 year, or Status-post surgical sterilization, or If of childbearing potential, utilization of barrier methods of birth control and willingness to undergo urine β-HCG testing prior to drug treatment and on every study day
Hgb A1C ≥6.5%, or
Fasting plasma glucose ≥126mg/dL, or
2-hour plasma glucose ≥200 mg/dL following 75gr oral glucose load

Key exclusion criteria (24 listed)

Type 1 diabetes
Poorly controlled T2DM, defined as Hgb A1C>8.7%
Use of anti-diabetic medications other than metformin for at least 12 months prior to initiation of the study
Secondary hypertension
Subjects who have participated in a weight-reduction program during the last 6 months and whose weight has increased or decreased more than 5 kg over the preceding 6 months

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
PlaceboAlso: Microcrystalline celluloseSubjects will receive two capsules of placebo to preserve the blinding of the study. In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.	Drug	Amlodipine, Ramipril, Valsartan
SitagliptinAlso: JanuviaSubjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.	Drug	Amlodipine, Ramipril, Valsartan
AprepitantAlso: EmendSubjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.	Drug	Amlodipine, Ramipril, Valsartan
Mixed Meal Test (MMT)The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.	Other	Amlodipine, Ramipril, Valsartan

Primary outcome

Mean Arterial Blood Pressure
Time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
The primary analyses will focus on mean arterial blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Heart Rate
Time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Norepinephrine (NE) Concentrations
Time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.

9 secondary outcomes

Low Frequency Variability of Blood Pressure Activity
Time frame: for 5 minutes on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Glucose
Time frame: fasting at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Insulin
Time frame: fasting insulin measured at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitatliptin+aprepitant)
Dipeptidyl Peptidase IV (DPP4) Activity
Time frame: for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Angiotensin Converting Enzyme (ACE) Activity
Time frame: for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)
Mean Arterial Blood Pressure
Time frame: Value provided is the AVERAGE of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
Heart Rate
Time frame: Value provided is the average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.
Neuropeptide Y
Time frame: Neuropeptide Y concentration prior to ingestion of the mixed meal.
24hr Urinary Testing for Sodium
Time frame: Urine was collected for sodium for 24 hrs prior to each of the study days listed below. Study days occurred after each 7-day treatment arm (placebo/placebo, sitagliptin/placebo, or sitagliptin/aprepitant) within 3 anti-hypertensive groups.

Results and safety

Results posted to the registry on 26 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine	36	36
Ramipril	35	33
Valsartan	35	31

Primary outcome: Mean Arterial Blood Pressure

Time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant). Mean (Standard Deviation). Unit: mmHg

Measure	Amlodipine Plus Placebo/Placebo n = 33	Amlodipine Plus Sitagliptin/Placebo n = 33	Amlodipine Plus Sitagliptin/Aprepitant n = 33	Ramipril Plus Placebo/Placebo n = 27	Ramipril Plus Sitagliptin/Placebo n = 25	Ramipril Plus Sitagliptin/Aprepitant n = 28	Valsartan Plus Placebo/Placebo n = 28	Valsartan Plus Sitagliptin/Placebo n = 29	Valsartan Plus Sitagliptin/Aprepitant n = 29
Value	94.42 (7.53)	93.41 (8.75)	91.54 (7.80)	90.21 (12.46)	89.88 (9.67)	86.95 (10.16)	94.54 (9.96)	93.71 (10.75)	93.98 (10.75)

Primary outcome: Heart Rate

Time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant). Mean (Standard Deviation). Unit: beats per minute

Measure	Amlodipine Plus Placebo/Placebo n = 33	Amlodipine Plus Sitagliptin/Placebo n = 33	Amlodipine Plus Sitagliptin/Aprepitant n = 33	Ramipril Plus Placebo/Placebo n = 27	Ramipril Plus Sitagliptin/Placebo n = 25	Ramipril Plus Sitagliptin/Aprepitant n = 28	Valsartan Plus Placebo/Placebo n = 28	Valsartan Plus Sitagliptin/Placebo n = 29	Valsartan Plus Sitagliptin/Aprepitant n = 29
Value	69.59 (9.75)	70.43 (9.79)	69.41 (9.84)	66.58 (7.71)	66.30 (8.16)	66.15 (8.06)	66.19 (9.19)	65.86 (8.46)	65.10 (8.52)

Primary outcome: Norepinephrine (NE) Concentrations

Time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant). Mean (Standard Deviation). Unit: pg/mL

Measure	Amlodipine Plus Placebo/Placebo n = 32	Amlodipine Plus Sitagliptin/Placebo n = 32	Amlodipine Plus Sitagliptin/Aprepitant n = 32	Ramipril Plus Placebo/Placebo n = 27	Ramipril Plus Sitagliptin/Placebo n = 25	Ramipril Plus Sitagliptin/Aprepitant n = 27	Valsartan Plus Placebo/Placebo n = 28	Valsartan Plus Sitagliptin/Placebo n = 28	Valsartan Plus Sitagliptin/Aprepitant n = 28
Value	741.65 (660.82)	730.88 (613.69)	610.65 (587.19)	470.69 (474.88)	627.55 (593.92)	649.39 (624.67)	874.22 (863.75)	986.31 (1114.67)	1013.54 (1073.91)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected through study completion or for approximately 15 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Washout Prior to Amlodipine	0 of 36 (0%)	4 of 36 (11.1%)	0 of 36
Amlodipine Alone	0 of 36 (0%)	1 of 36 (2.8%)	0 of 36
Amlodipine Plus Sitagliptin/Placebo	0 of 33 (0%)	7 of 33 (21.2%)	0 of 33
Amlodipine Plus Placebo/Placebo	0 of 33 (0%)	4 of 33 (12.1%)	0 of 33
Amlodipine Plus Sitagliptin/Aprepitant	0 of 33 (0%)	9 of 33 (27.3%)	0 of 33
Washout Prior to Ramipril	0 of 35 (0%)	3 of 35 (8.6%)	0 of 35
Ramipril Alone	0 of 33 (0%)	3 of 33 (9.1%)	0 of 33
Ramipril Plus Placebo/Placebo	0 of 27 (0%)	3 of 27 (11.1%)	0 of 27
Ramipril Plus Sitagliptin/Placebo	0 of 25 (0%)	1 of 25 (4%)	0 of 25
Ramipril Plus Sitagliptin/Aprepitant	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28
Washout Prior to Valsartan	1 of 35 (2.9%)	5 of 35 (14.3%)	0 of 35
Valsartan Alone	1 of 31 (3.2%)	0 of 31 (0%)	0 of 31
Valsartan Plus Placebo/Placebo	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28
Valsartan Plus Sitagliptin/Placebo	0 of 29 (0%)	5 of 29 (17.2%)	0 of 29
Valsartan Plus Sitagliptin/Aprepitant	0 of 29 (0%)	3 of 29 (10.3%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33001556Mashayekhi M, Wilson JR, Jafarian-Kerman S, Nian H, Yu C, Shuey MM, Luther JM, Brown NJ. Association of a glucagon-like peptide-1 receptor gene variant with glucose response to a mixed meal. Diabetes Obes Metab. 2021 Jan;23(1):281-286. doi: 10.1111/dom.14216. Epub 2020 Oct 22.

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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

Nancy J Brown, M.D. principal investigator

Vanderbilt University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sitagliptin, Aprepitant and Mixed Meal Test (MMT) in people with Type 2 Diabetes Mellitus and Hypertension, run by Vanderbilt University at 1 site in United States.

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 11 inclusion and 24 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 2 Mar 2022. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Arterial Blood Pressure (time frame: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130687, which also lists 1 linked publication.

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 2 Mar 2022.