Status:
WITHDRAWN
Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
Lead Sponsor:
Texas A&M University
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central ...
Detailed Description
This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/ab...
Eligibility Criteria
Inclusion
- Inclusion criteria CKD subjects
- Ability to walk, sit down and stand up independently
- Age 55 years or older
- Ability to lie in supine or elevated position for 7 hours
- Diagnosis of kidney disease; undergoing hemodialysis
- Clinically stable condition; no hospitalization 4 weeks preceding first study day
- Willingness and ability to comply with the protocol
- Inclusion criteria healthy subjects:
- Healthy male or female according to the investigator's or appointed staff's judgment
- Ability to walk, sit down and stand up independently
- Age 55 years or older (older control group)
- Ability to lay in supine or elevated position for 7 hours
- No diagnosis of CKD
- Willingness and ability to comply with the protocol
- Exclusion Criteria all subjects:
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Body mass index \>40 kg/m2 (healthy subjects only)
- Any other condition that would interfere with the study or safety of the patient (according to the PI or nurse)
- Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- Use of long-term oral corticosteroids or short course of oral corticosteroids within 4 weeks preceding first study day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- (Possible) pregnancy
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01890811
Start Date
June 1 2013
End Date
December 1 2016
Last Update
May 1 2015
Active Locations (1)
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1
Texas A&M University
College Station, Texas, United States, 77843