Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function

Chronic Kidney Failure Clinical Trial

Official title:

Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01890811
• Other study ID #: 2013-0294
• Status: Withdrawn
• Phase: N/A
• First received: June 27, 2013
• Last updated: April 29, 2015
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. Attempts to reverse weight and muscle loss in CKD and improve nutritional status by nutritional supplementation have been unsuccessful and there are currently no approved therapies.

Purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CKD patients compared to matched healthy controls. Additionally, to examine whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy controls. This will provide required information that will lead to implement new strategies to develop optimal nutritional regimen in order to enhance nutritional status, quality of life and survival in relation to kidney disease.

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/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7.5 hours.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Boost High Protein
Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net whole-body protein synthesis	Change in whole-body protein synthesis rate after intake of meal	0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal	No
Secondary	Citrulline Rate of appearance	Plasma enrichment of citrulline	Postabsorptive state during 3 hours	No
Secondary	Glucose absorption	Recovery of 3-O-Methyl-D-glucose in the urine.	7 hours	No
Secondary	Gut permeability	Recovery of rhamnose/lactulose in urine	7 hours	No
Secondary	Skeletal and respiratory muscle strength	Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.	1 day	No
Secondary	Cognitive function	Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism	1 day	No
Secondary	Fatty acid digestion after feeding	Enrichment in palmitic acid and tripalmitin fatty acids in plasma	0,15,30,45,60,75,90,105,120,150,180,210 min post-meal	No
Secondary	Protein digestion after feeding	Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina	0,15,30,45,60,75,90,105,120,150,180,210, min post-meal	No
Secondary	Arginine turnover rate	Arginine enrichment in plasma	Postabsorptive state during 3 hours	No
Secondary	Whole body collagen breakdown rate	Hydroxyproline enrichment in plasma	Postabsorptive state during 3 hours	No
Secondary	Tryptophan turnover rate	Tryptophan enrichment in plasma	Postabsorptive state during 3 hours	No
Secondary	Insulin response to feeding	Acute change from postabsorptive state after intake of meal	During 3 hours after feeding	No
Secondary	Fat-free mass	Characteristics of study subjects	Postabsorptive state during 15 min	No
Secondary	Myofibrillar protein breakdown rate	3-Methylhistidine enrichment in plasma	0,15,30,45,60,75,90,105,120,150,180,210 min post-meal	No
Secondary	Glycine rate of appearance	Glycine enrichment in plasma	Postabsorptive state during 3 hours	No
Secondary	Taurine turnover rate	Enrichment of taurine in plasma	Postabsorptive state during 3 hours	No