Insulin SensitivityNCT01252238
Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance
A study testing Aliskiren, Valsartan and Aliskiren and Amlodipine in people with Insulin Sensitivity and Aortic Compliance, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows: Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies glucose… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin Sensitivity, Aortic Compliance, Diastolic Function
- What is being tested?
- Aliskiren, Valsartan and Aliskiren and Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18-70 years old
- BMI =/< 35
- BP: BP > 145/95 on no BP medication or on 3 or less BP medications
- HOMA =>2.5
- Any race
Who cannot join
- 4 or more BP medications
- Intolerance or known prior adverse history from taking the medications amlodipine, aliskiren or valsartan
- BP >170/110 on screening exam
- Alcohol intake >12 oz per week
- Current smoking
- Recreational drug use
Show all 22Show fewer
- Known or suspected secondary hypertension
- Known history of coronary artery disease, cerebrovascular disease or congestive heart failure
- History or known kidney disease (eGFR <50cc/min)
- Diabetes or current metformin use, or HbA1c >=6.5% on screen
- Steroid use (oral or inhaled, chronic or within the past 6 months)
- Clinically significant screening lab abnormalities (See attached "Screening Labs Acceptable Ranges")
- Evidence of ischemia or heart block on screening electrocardiogram (greater than type I-second degree heart block, left bundle branch block, or ST-T wave changes in 2 or more contiguous leads).
- Acute hospitalizations including surgery in the past 6 months
- Chronic use of non-steroidal anti-inflammatory or narcotic medications
- Women who are pregnant or nursing, or wish to become pregnant and/or who can not agree or tolerate two forms of birth control during the study period:
- Acceptable birth control methods for use in this study are:
- hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- intrauterine device (IUD)
- abstinence (no sex)
- Significant concomitant medical illnesses (cancer, chronic active immunological conditions, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows:
Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies glucose homeostasis and insulin sensitivity.
Read more
To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed basally and after twelve weeks of treatment with either a calcium channel blocker with placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with a renin inhibitor and an angiotensin receptor antagonist.
Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium intake.
The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance (characteristic aortic impedance) will be measured at baseline and then after acute and chronic renin inhibition:
- Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high and low dietary sodium intake conditions (~1 week each) before and after a single dose of a renin inhibitor.
- Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at baseline and after 12 weeks of each of the three drug treatment arms above.
The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.
- Conditions
- Insulin Sensitivity, Aortic Compliance, Diastolic Function
- Being tested
- Aliskiren, Valsartan and Aliskiren, Amlodipine
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
Valsartan and AliskirenDrug
Subject taking combination of valsartan and aliskiren.
AmlodipineDrug
Taking Amlodipine as prescribed by MD for management of high blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan and Aliskiren | Placebo comparator | Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg) Receives: Drug: Valsartan and Aliskiren |
| Aliskiren | Experimental | Not described Receives: Drug: Aliskiren |
| Placebo Group | Placebo comparator | Only taking Amlodipine Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity by HOMA at 12 Weeks
The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value
Measured: 12 weeks
Secondary outcomes (1)
Aortic Compliance
Characteristic aortic imedeance, dynes x s/cm5
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Study sponsor terminated study due to AE's reported with valsartan and aliskiren
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.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
- Investigators
- Jonathan Williams, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252238
- Sponsor's protocol ID
- 2010p001286
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2010
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance
- ClinicalTrials.gov ID
- NCT01252238
- Acronym / sponsor ID
- 2010p001286
- Conditions
- Insulin Sensitivity, Aortic Compliance, Diastolic Function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study sponsor terminated study due to AE's reported with valsartan and aliskiren
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 5 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows:
Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies glucose homeostasis and insulin sensitivity.
To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed basally and after twelve weeks of treatment with either a calcium channel blocker with placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with a renin inhibitor and an angiotensin receptor antagonist.
Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium intake.
The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance (characteristic aortic impedance) will be measured at baseline and then after acute and chronic renin inhibition:
- Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high and low dietary sodium intake conditions (~1 week each) before and after a single dose of a renin inhibitor.
- Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at baseline and after 12 weeks of each of the three drug treatment arms above.
The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valsartan and Aliskiren | Placebo comparator | Drug: Valsartan and AliskirenValsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg) |
| Aliskiren | Experimental | Drug: Aliskiren |
| Placebo Group | Placebo comparator | Drug: AmlodipineOnly taking Amlodipine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, 18-70 years old
- BMI =/< 35
- BP: BP > 145/95 on no BP medication or on 3 or less BP medications
- HOMA =>2.5
- Any race
Key exclusion criteria (22 listed)
- 4 or more BP medications
- Intolerance or known prior adverse history from taking the medications amlodipine, aliskiren or valsartan
- BP >170/110 on screening exam
- Alcohol intake >12 oz per week
- Current smoking
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 |
|---|---|---|
| AliskirenAliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks. | Drug | Aliskiren |
| Valsartan and AliskirenSubject taking combination of valsartan and aliskiren. | Drug | Valsartan and Aliskiren |
| AmlodipineTaking Amlodipine as prescribed by MD for management of high blood pressure. | Drug | Placebo Group |
Primary outcome
Change in Insulin Sensitivity by HOMA at 12 Weeks
Time frame: 12 weeks
The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value
1 secondary outcome
Aortic Compliance
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Insulin Sensitivity
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Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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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.
Jonathan Williams, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aliskiren, Valsartan and Aliskiren and Amlodipine in people with Insulin Sensitivity and Aortic Compliance, run by Brigham and Women's Hospital 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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 13 Feb 2018. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2013). 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?
Change in Insulin Sensitivity by HOMA at 12 Weeks (time frame: 12 weeks). 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 13 Feb 2018.