Diabetes Type 2NCT01165983

The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

A study testing Aliskiren in people with Diabetes Type 2, run by Beth Israel Deaconess Medical Center 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

The purpose of this research is to study and determine the effects of Aliskiren on blood vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial function by 30% or more in comparison to the placebo group. Read more about this study

Who is it for?: Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Type 2
What is being tested?: Aliskiren
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Jan 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 21 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ages of 21-80 years
Subjects "at risk" of developing type 2 Diabetes Mellitus (First degree relatives history of type 2 Diabetes Mellitus, History of gestational Diabetes, Known impaired glucose tolerance, Impaired fasting plasma glucose 100-126 mg/dl at the time of enrollment)
Ages of 21-80 years
Type 2 Diabetes Mellitus stable and not expected to change during the study period

Who cannot join

Treatment with Aliskiren (Tekturna)
Smokers (use of tobacco products in the previous 3 months)
Active or Uncontrolled Cardiovascular Disease
Myocardial infarction, or angina within 12 months of study participation
Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening)
CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest)

Show all 51Show fewer

Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation
Uncontrolled Hypertension (SBP >180 mmHg or DBP >105 mmHg; 2 abnormal readings during visit)
History of previous hypotensive episodes
Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment
Hyperkalemia (serum potassium >5.0 meq/L)
Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)
Any Other Serious Chronic Disease Requiring Active Treatment
Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
Pregnancy
Taking Any of the Following Medications:
Systemic (not inhaled) Glucocorticoids
Antineoplastic Agents
Cyclosporine, Ketoconazole, Furosemide, Warfarin
Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past
History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations
Group 2. Type 2 Diabetic Patients
Treatment with Aliskiren (Tekturna)
Smokers (use of tobacco products in the previous 3 months)
Active or Uncontrolled Cardiovascular Disease
Myocardial infarction, or angina within 12 months of study participation
Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening)
CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest)
Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation
Uncontrolled Hypertension (SBP >180 mmHg or DBP >105 mmHg; 2 abnormal readings during visit)
History of previous hypotensive episodes
Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment
Hyperkalemia (serum potassium >5.0 meq/L)
Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)
Any Other Serious Chronic Disease Requiring Active Treatment
Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators
Pregnancy
Taking Any of the Following Medications:
Systemic (not inhaled) Glucocorticoids
Antineoplastic Agents
Cyclosporine, Ketoconazole, Furosemide, Warfarin
Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis
Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past
History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations
Severe proliferative retinopathy that renders the subject legally blinded
Previous diagnosis of severe gastroparesis diabeticorum due to autonomic neuropathy that has necessitated hospital admission
Presence of non-healing foot ulceration due to severe peripheral diabetic neuropathy
Documented diabetic nephropathy manifested as macro-albuminuria, (2 of 3 urine specimens collected within a 3-6 month period with urine albumin>300 ug/mg creatinine

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory
Boston, Massachusetts, 02215

Other trials in United States

About this study

Conditions: Diabetes Type 2
Being tested: Placebo, Aliskiren
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
0mg tablet, taken orally for 12 weeks daily
AliskirenDrug
Also called Trade name: Tekturna
150mg tablet, taken orally for 12 weeks daily

Study groups in NCT01165983
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Aliskiren	Experimental	Not described Receives: Drug: Aliskiren

What is being measured

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

Flow Mediated Vasodilation
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Measured: Baseline
Flow Mediated Vasodilation
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Measured: 12 Weeks post-randomization
Nitroglycerin Induced Dilation
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Measured: Baseline
Nitroglycerine Induced Vasodilation
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Measured: 12 Weeks post-randomization
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.
Measured: Baseline
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).
Measured: 12 Weeks post-randomization

Secondary outcomes (14)

Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL
Measured: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL
Measured: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL
Measured: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL
Measured: 12 Weeks post-randomization

Timeline

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

Nov 2009Jan 2012

First posted20 Jul 2010 (estimated)
Study startNov 2009
Primary completionJan 2012

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 Diabetes Type 2Studies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01165983
Sponsor's protocol ID: 2009P000233
Status last verified: Feb 2017
First submitted: 15 Dec 2009
Last updated: 28 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dushay JR, Tecilazich F, Kafanas A, Magargee ML, Auster ME, Gnardellis C, Dinh T, Veves A. Aliskiren improves vascular smooth muscle function in the skin microcirculation of type 2 diabetic patients with normal renal function. J Renin Angiotensin Aldosterone Syst. 2015 Jun;16(2):344-52. doi: 10.1177/1470320313489060. Epub 2013 May 13.
PubMed 23670354

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
ClinicalTrials.gov ID: NCT01165983
Acronym / sponsor ID: 2009P000233
Conditions: Diabetes Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: Novartis Pharmaceuticals
Study start: Nov 2009
Primary completion: Jan 2012 (actual)
First posted: 20 Jul 2010 (estimated)
Results: Posted 9 Feb 2015

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Aliskiren	Experimental	Drug: Aliskiren

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ages of 21-80 years
Subjects "at risk" of developing type 2 Diabetes Mellitus (First degree relatives history of type 2 Diabetes Mellitus, History of gestational Diabetes, Known impaired glucose tolerance, Impaired fasting plasma glucose 100-126 mg/dl at the time of enrollment)
Ages of 21-80 years
Type 2 Diabetes Mellitus stable and not expected to change during the study period

Key exclusion criteria (51 listed)

Treatment with Aliskiren (Tekturna)
Smokers (use of tobacco products in the previous 3 months)
Active or Uncontrolled Cardiovascular Disease
Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)
Renal Disease (creatinine > 1.7 mg/dL for women and >2.0 mg/dL for men and/or estimated GFR <30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment

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
Placebo0mg tablet, taken orally for 12 weeks daily	Drug	Placebo
AliskirenAlso: Trade name: Tekturna150mg tablet, taken orally for 12 weeks daily	Drug	Aliskiren

Primary outcome

Flow Mediated Vasodilation
Time frame: Baseline
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Flow Mediated Vasodilation
Time frame: 12 Weeks post-randomization
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Nitroglycerin Induced Dilation
Time frame: Baseline
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Nitroglycerine Induced Vasodilation
Time frame: 12 Weeks post-randomization
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
Time frame: Baseline
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
Time frame: 12 Weeks post-randomization
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).

14 secondary outcomes

Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL
Time frame: 12 Weeks post-randomization
Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL
Time frame: 12 Weeks post-randomization

Results and safety

Results posted to the registry on 9 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	51	46
Aliskiren	49	42

Primary outcome: Flow Mediated Vasodilation

Time frame: Baseline. Mean (Standard Deviation). Unit: percentage change over baseline

Measure	Subjects at Risk of DMII n = 48	T2DM Patients n = 52
Value	4.8 (0.7)	4.4 (2.6)

Primary outcome: Flow Mediated Vasodilation

Time frame: 12 Weeks post-randomization. Median (Inter-Quartile Range). Unit: percent change over baseline

Measure	Placebo n = 46	Aliskiren n = 42
At risk of T2DM, Placebo n=21, Aliskiren n=20	0.3 (-0.3 to 1.8)	0.8 (0.3 to 2.1)
Diabetic Patients, Placebo n=25, Aliskiren n=22	0.4 (0.0 to 1.0)	0.9 (0.0 to 1.4)

Population analysed: Number of subjects that completed the study

Primary outcome: Nitroglycerin Induced Dilation

Time frame: Baseline. Mean (Standard Deviation). Unit: percent change

Measure	Subjects at Risk of DMII n = 48	T2DM Patients n = 52
Value	16.5 (4.8)	15.2 (5.0)

Primary outcome: Nitroglycerine Induced Vasodilation

Time frame: 12 Weeks post-randomization. Median (Inter-Quartile Range). Unit: percent change

Measure	Placebo n = 46	Aliskiren n = 42
At risk of T2DM, Placebo n=21, Aliskiren n=20	0.4 (-2.4 to 3.7)	-0.8 (-1.8 to 2.5)
Diabetic Patients, Placebo n=25, Aliskiren n=22	-1.4 (-3.9 to 0.4)	-0.3 (-3.4 to 1.5)

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 46 (0%)	6 of 46 (13%)	Not reported
Aliskiren	4 of 42 (9.5%)	7 of 42 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23670354Dushay JR, Tecilazich F, Kafanas A, Magargee ML, Auster ME, Gnardellis C, Dinh T, Veves A. Aliskiren improves vascular smooth muscle function in the skin microcirculation of type 2 diabetic patients with normal renal function. J Renin Angiotensin Aldosterone Syst. 2015 Jun;16(2):344-52. doi: 10.1177/1470320313489060. Epub 2013 May 13.

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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.

Aristidis Veves, MD principal investigator

Beth Israel Deaconess Medical Center

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 in people with Diabetes Type 2, run by Beth Israel Deaconess Medical Center 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 4 inclusion and 51 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 28 Mar 2017. 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 9 Feb 2015). 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?

Flow Mediated Vasodilation (time frame: Baseline). The study lists 6 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 NCT01165983, 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 28 Mar 2017.