NCT01165983

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

December 15, 2009

Results QC Date

November 10, 2014

Last Update Submit

February 27, 2017

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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).

    12 Weeks post-randomization

Secondary Outcomes (14)

  • Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL

    12 Weeks post-randomization

  • Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL

    12 Weeks post-randomization

  • Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL

    12 Weeks post-randomization

  • Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL

    12 Weeks post-randomization

  • Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL

    12 Weeks post-randomization

  • +9 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Aliskiren

EXPERIMENTAL
Drug: Aliskiren

Interventions

PlaceboDRUG

0mg tablet, taken orally for 12 weeks daily

Placebo
AliskirenDRUG

150mg tablet, taken orally for 12 weeks daily

Also known as: Trade name: Tekturna
Aliskiren

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +38 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center, Joslin Foot Center & Microcirculation Laboratory

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 23670354DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Aristidis Veves, Research Director
Organization
Beth Israel Deaconess Medical Center
aveves@bidmc.harvard.edu
617-632-7075

Study Officials

  • Aristidis Veves, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rongxiang Xu, MD Professor of Surgery in the Field of Regenerative Therapeutics

Study Record Dates

First Submitted

December 15, 2009

First Posted

July 20, 2010

Study Start

November 1, 2009

Primary Completion

January 1, 2012

Last Updated

March 28, 2017

Results First Posted

February 9, 2015

Record last verified: 2017-02

Locations

US(1)