Alpha-Adrenoceptor Vascular Function In Chronic Kidney Disease Focus On The Role Of Endothelial Nitric Oxide

NCT00356265 | Terminated Results

• 2 other identifiers: HUM 000002615R33DK071222
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about why most patients with early stages of kidney disease have high blood pressure. We know the body produces natural substances that cause blood vessels to open wider to carry more blood when needed. An example is during exercise. Other natural substances cause blood vessels to get smaller and slow down blood flow when needed. An example is when people are cold. The balance between these substances is important. People with kidney disease and high blood pressure do not have the normal balance of these substances. This study will include 3 groups of people, people with normal blood pressure, people with high blood pressure and people with kidney disease.

• Subjects will have a screening physical examination, including an ECG and laboratory tests
• Subjects with high blood pressure may not take their regular blood pressure medication for 3 weeks prior to the inpatient GCRC study
• Subjects will be given intra-arterial medications that will cause changes in the blood vessels during the in-patient study. The study will then compare the responses of the three groups. A GFR test will be done to confirm the renal function of the group with chronic kidney disease. These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1 vasoreactivity in subjects with progressive renal disease. This will lay the groundwork for new strategies in the treatment and prevention of vascular disease among the rapidly growing group of individuals with CKD.

Conditions

Chronic Kidney Disease; Hypertension

Keywords

Blood Pressure Nitric Oxide; L-NMMA; Phenylephrine; Vasoreactivity; Blood Pressure

Outcome Measures

Primary Outcomes (2)

• α1-adrenoceptor Vasoreactivity With L-NMMA

  Vasoreactivity is defined as Forearm blood flow, dose response curve; ml per minute per log of phenylephrine, or FABF ml/min/logPE; The x axis is the ml/min value and the y axis is the log Phenylephrine concentration.

  up to 8 hours

• α1-adrenoceptor Vasoreactivity With Endogenous ADMA

  up to 8 hours

Study Arms (3)

CKD

EXPERIMENTAL

Drug: Procedure: Regional phenylephrine arterial infusion

Hypertension group

ACTIVE COMPARATOR

Drug: Procedure: Regional phenylephrine arterial infusion

Normotensive group

ACTIVE COMPARATOR

Drug: Procedure: Regional phenylephrine arterial infusion

Interventions

Procedure: Regional phenylephrine arterial infusion DRUG

CKD; Hypertension group; Normotensive group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and Women-18 to 55 years of age.
• There are three groups of volunteers.
• Group A. People who are hypertensive with kidney disease. When not taking blood pressure medicines, blood pressure must have a systolic between 140-170 mmHg. Diastolic must be between 90-109 mmHg.Kidney function should be around half of normal. Urine protein must be no more than 1 gram in a 24-hour urine time period.
• Group B. People who are hypertensive without kidney disease. Blood pressure must have a systolic between 140-170 mmHg. Diastolic must be between 90-109 mmHg. Kidney function should be normal. Normal amounts of protein in their urine.
• Group C. People who are normotensive. Blood pressure must have a systolic below 131/mmHg. Diastolic must be below 81 mmHg. Kidney function should be normal. No more than normal amounts of protein in their urine.

You may not qualify if:

• People with:
• Diabetes
• Lung disease
• Stomach disease
• Liver disease
• Blood vessel disease
• Heart disease
• Hereditary blood disorders
• Hematocrit (amount of red blood cells) less than 30%
• Current tobacco use
• Kidney disease who require dialysis
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Crystal Gadegbeku
• Organization: University of Michigan

crystal.Gadebeku@tuhs.temple.edu

Study Officials

• Crystal A Gadegbeku, MD

  Assistant Professor of Medicine, University of Michigan Health System, Department of Internal Medicine, Division of Nephrology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: All three groups will have the same intervention

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: July 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Locations

US (1)