- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01494909
Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function
Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An impaired intestinal digestion and absorption capacity is one of the main factors responsible for the malnutrition in CF. This impairment starts early in life, leading to malnutrition, muscle weakness, impaired immune and lung function associated with poor prognosis. As low BMI and body weight is strongly associated with morbidity and mortality, a reduction in weight loss in CF and its manifestations would save the healthcare system substantially per year. Simple methods to measure the digested portions and utilization of nutrients and the effectiveness of pancreatic enzyme preparations and medications in CF are not available. Developing a panel of methods to accurately measure gut digestion, absorption and function will lead to studies optimizing nutritional regimen and pancreatic enzyme replacement therapy in CF. Furthermore, it will provide detailed insight in the disease and age related mechanisms of gut dysfunction in CF. Finally, it will provide required information that will lead to implement new strategies to improve gut health in order to enhance nutritional status, quality of life and survival.
The hypothesis is that intestinal macronutrient digestion, absorption and function in CF can be quantified by an innovative panel of methods using stable isotopes. With this panel of methods, information can be obtained on the effect of disease progression on lipid, protein and glucose digestion and absorption and on gut function in CF as well as in other diseases and conditions characterized by a compromised gut. Furthermore, the optimal nutritional regimen and pancreatic enzyme therapy if applicable can be evaluated in these diseases. In the present study the investigators will study: 1. Pediatric patients with CF at Arkansas Children's Hospital; 2. Adult patients with CF at University of Arkansas for Medical Sciences. 3. Healthy control subjects. Diagnosis of CF is made based on universal diagnostic criteria. All CF patients are characterized by abnormal lipid digestion based on clinical and or laboratory (72 hour fat analysis or fecal elastase measurement) diagnosis, and requiring pancreatic enzyme replacement therapy, and no presence of unstable metabolic diseases. Additional criteria for the CF pediatric inpatients are: admitted to ACH for treatment of exacerbations of CF disease, clinically stable. The CF outpatients are stable outpatients with pancreatic insufficiency.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adult subjects with CF
- Diagnosis of CF based on universal diagnostic criteria
- Pancreatic insufficiency based on clinical diagnosis
- Abnormal lipid digestion requiring pancreatic enzyme replacement therapy
- Age is 18 years and older.
- Admitted to UAMS for treatment of exacerbations of CF (inpatients) or under routine medical control at the CF center of UAMS
- Clinically stable CF at the time of enrollment
Healthy adults
- Age is 18 years and older at the time of enrollment.
- BMI between 18 and 35 kg/m2
Exclusion Criteria:
Pediatric and adult CF groups
- Unstable metabolic diseases including liver (cirrhosis) or renal disease
- Chronic respiratory failure with cor pulmonale
- Any other condition according to the principle investigator or study physician would interfere with proper conduct of study / safety of the patient
- Failure to give assent / informed consent
- Diagnosis of severe lung disease, defined as FEV1 < 35% predicted
Healthy adults
- Presence of acute or chronic unstable diseases such as liver, renal, heart or lung disease
- Previous surgery less than 4 weeks prior to the experiment
- Recent involuntary weight loss (>10% in the past 3 months)
- Any documented autoimmune disease
- Any other condition according to the principle investigator or study physician would interfere with collecting study samples
- Failure to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ensure plus
Ensure sip feeds during 6 hours.
After 2 hours pancreatic intake
|
Ensure plus sip feeds every 20 min during 6 hours.
After 2 hour pancreatic enzyme intake in CF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatty acid absorption during feeding and effect pancreatic enzyme intake
Time Frame: 8 hours
|
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein digestion during feeding and effect pancreatic enzyme intake
Time Frame: 8 hours
|
Ratio enrichment in plasma free phenylalanine vs from protein spirulina
|
8 hours
|
Glucose absorption during feeding and effect pancreatic enzyme intake
Time Frame: 8 hours
|
Plasma and urine 3-O-methyl-D-glucose
|
8 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on Ensure plus
-
Vanderbilt UniversityUniversity of OklahomaCompletedBladder CancerUnited States
-
London North West Healthcare NHS TrustCompleted
-
University of Dublin, Trinity CollegeAbbottUnknown
-
Singapore General HospitalAbbottWithdrawn
-
Seven Oaks Hospital Chronic Disease Innovation...University of Manitoba; Manitoba Egg FarmersNot yet recruitingFrailty | Kidney Disease, Chronic | Kidney Failure
-
James A. Haley Veterans Administration HospitalCompleted
-
Sengkang General HospitalAbbottActive, not recruitingFrailty | SarcopeniaSingapore
-
Caribbean Health Research CouncilThe University of The West IndiesCompletedHuman Immunodeficiency Virus (HIV) | Acquired Immune Deficiency Syndrome (AIDS)Jamaica
-
Instituto Aragones de Ciencias de la SaludRefbio2: Trans-Pyrenean cooperation network for biomedical researchCompletedMalnutrition | Cirrhosis | SarcopeniaSpain
-
National Yang Ming UniversityCompletedFrail Elderly Syndrome | Muscle Loss | Nutrition Disorders in Old AgeTaiwan