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

NCT ID: NCT01165983

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30

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.

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0mg tablet, taken orally for 12 weeks daily

Aliskiren

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

150mg tablet, taken orally for 12 weeks daily

Interventions

Placebo

0mg tablet, taken orally for 12 weeks daily

Intervention Type: DRUG

Aliskiren

150mg tablet, taken orally for 12 weeks daily

Intervention Type: DRUG

Other Intervention Names

Trade name: Tekturna

Eligibility Criteria

Inclusion Criteria

1. Ages of 21-80 years

2. 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)

1. Ages of 21-80 years

2. Type 2 Diabetes Mellitus stable and not expected to change during the study period

Exclusion Criteria

1. Treatment with Aliskiren (Tekturna)

2. Smokers (use of tobacco products in the previous 3 months)

3. 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

4. Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)

5. 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

6. Hyperkalemia (serum potassium >5.0 meq/L)

7. Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)

8. Any Other Serious Chronic Disease Requiring Active Treatment

9. Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators

10. Pregnancy

11. 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

12. 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

13. 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

1. Treatment with Aliskiren (Tekturna)

2. Smokers (use of tobacco products in the previous 3 months)

3. 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

4. Liver Disease (AST, ALT, Alk Phos levels > 2x UNL)

5. 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

6. Hyperkalemia (serum potassium >5.0 meq/L)

7. Severe Dyslipidemia (TG > 600 mg/dL or Cholesterol >350 mg/dL)

8. Any Other Serious Chronic Disease Requiring Active Treatment

9. Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators

10. Pregnancy

11. 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

12. 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

13. 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

14. Severe proliferative retinopathy that renders the subject legally blinded

15. Previous diagnosis of severe gastroparesis diabeticorum due to autonomic neuropathy that has necessitated hospital admission

16. Presence of non-healing foot ulceration due to severe peripheral diabetic neuropathy

17. 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Aristidis Veves

Rongxiang Xu, MD Professor of Surgery in the Field of Regenerative Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aristidis Veves, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23670354 (View on PubMed)

Other Identifiers

2009P000233

Identifier Type: -

Identifier Source: org_study_id