Effect of Angiotensin Converting Enzyme Inhibitor, Lisinopril, on Renal Blood Flow and Its Correlation With Proteinuria Reduction in Subjects With Type 2 Diabetes and Kidney Disease

NCT01101269 | Terminated

• 1 other identifier: 14815
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the effect of a blood pressure medication, Lisinopril, or similar drugs in that class, on the flow of blood to the kidneys. In this study, we will compare blood flow to the kidneys in healthy people that do not have diabetes or kidney disease with people that have diabetes and evidence of kidney disease.

Conditions

Type 2 Diabetes

Keywords

Diabetic nephropathy

Outcome Measures

Primary Outcomes (2)

• Change in renal blood flow (RBF)

  We will use Contrast Enhanced Ultrasound using Definity as the contrast agent to monitor changes in renal blood flow (RBF).

  Study day 10

• Change in renal blood flow (RBF)

  Compared to Study Day 17

Secondary Outcomes (2)

• Change in Proteinuria

  Study day 10

• Change in Proteinuria

  Compared to study day 17

Study Arms (2)

Subjects with diabetic nephropathy

EXPERIMENTAL

Renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured both on and off angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB).

Drug: ACEI or ARB

Healthy volunteers

ACTIVE COMPARATOR

Renal blood flow (RBF) will be measured using contrast enhanced ultrasound (CEU) and urine protein will be measured both on and off angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB).

Drug: Lisinopril

Interventions

ACEI or ARB DRUG

Subjects will be asked to discontinue their usual ACE inhibitor or Angiotensin Receptor Blocker (ARB) for ten days, undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then resume their usual ACEI or ARB for ten days, then undergo another CEU using Definity as the contrast agent.

Subjects with diabetic nephropathy

Lisinopril DRUG

Subjects will be undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then take Lisinopril 10 mg every day for 7 days, after which they will undergo another CEU using Definity as the contrast agent.

Healthy volunteers

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusion For subjects with diabetic nephropathy, 1. Adults (ages 40 - 75 years) 2. Diagnosis of type 2 diabetes for more than 5 years 3. Evidence of diabetic nephropathy as evidenced by a. More than 150 mg of proteinuria per day in a 24-hour urine collection, or a spot morning urine protein to creatinine of greater than 0.15, or a spot morning urine albumin to creatinine ratio greater than 100 confirmed on two separate occasions within 12 months 4. Treatment with a blocker of the renin -angiotensin-aldosterone system (either ACE inhibitor or ARB) For healthy controls, 1. Adults (ages 40 - 75 years) 2. Good general health Exclusion For subjects with diabetic nephropathy, 1. Type 1 diabetes 2. Glomerular filtration rate less than 40 ml/min/1.73 m2 by MDRD formula 3. Hemoglobin A1C greater than 10% 4. Blood pressure greater than 150/90 mm Hg or less than 100/55 mm Hg 5. History of kidney transplantation 6. Oxygen saturation is less than 80% 7. History of unstable cardiopulmonary conditions, known intracardiac shunts, or pulmonary hypertension 8. History of active cancer within the last 3 years For healthy controls, 1. History or clinical evidence of any chronic disease 2. Chronic and regular use of any medications except for oral contraceptives and vitamins 3. Clinically significant abnormal screening laboratory values 4. Pregnancy or lactation for women 5. Blood pressure at screening visit less than 110/60 6. History of unstable cardiopulmonary conditions, known intracardiac shunts, or pulmonary hypertension 7. History of active cancer within the last 3 years

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Interventions

Angiotensin-Converting Enzyme Inhibitors; Lisinopril

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kambiz Kalantarinia, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 9, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

US (1)