Chronic Pancreatitis
Conditions
Keywords
pain, depression, cytokines, well-being
Brief summary
An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is given to all participants for 3 months, and assessments will occur at intake and after 3 months.
Detailed description
This is an open label pilot study to determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on chronic pancreatitis. ALC is an acetylated form of naturally occurring amino acid L-carnitine ((R)-3-Acetyloxy-4-trimethylammonio-butanoate) found in red meat and is readily commercially available. Supplementation with ALC may decrease pain and improve overall health based on our preclinical treatment studies in rats with high fat and alcohol induced pancreatitis. In rats, ALC reduces pain measures, improves glucose tolerance, decreases lipid peroxidation, and Ki67 cellular injury biomarker, and improves pancreatic histopathology. The measurable outcomes of this clinical study are patients' questionnaire scores for: pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The questionnaires are given at intake and at experiment end (3 months). Participants will receive ALC for 3 months. These findings will indirectly determine the effect of ALC on the function and inflammatory state of the pancreas. Currently, there is no specific therapy for chronic pancreatitis, and its pathophysiology is still poorly understood. It is known that chronic pancreatitis is caused by ongoing inflammation in the pancreas, yet, no pharmacological intervention exists that optimally addresses this. The broad actions of ALC as an antioxidant and anti-inflammatory agent as well as its ability to reduce side-effects of alcohol cessation make it a perfect compound to pursue for the treatment of pancreatitis.
Interventions
DIETARY_SUPPLEMENTacetyl-L-carnitine 1000mg 2X per day for 3 months
non-essential dietary amino acid
Sponsors
University of Kentucky
Karin High
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Only patients with chronic pancreatitis are included.
Exclusion criteria
* Patients with pancreatic pseudocysts, abscesses, pseudoaneurysms, pancreatitic fistulas, pancreatic adenocarcinoma, * Females that are pregnant or lactating * Children are excluded. * Patients suffering from seizure or thyroid disorders are also excluded due to possible exaggeration of their symptoms from taking ALC according to manufacturer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 3 months | McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Well Being | 3 months | Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy |
| Generalized anxiety disorder 7-item (GAD-7) Scoring | 3 months | 5-\< 10 Mild Anxiety 10-\<15 Moderate Anxiety \>15 Severe Anxiety 5-\< 10 Mild Anxiety 10-\<15 Moderate Anxiety \>15 Severe Anxiety 5-\< 10 Mild Anxiety 10-\<15 Moderate Anxiety \>15 Severe Anxiety 5-\< 10 Mild Anxiety; 10-\<15 Moderate Anxiety; \>15 Severe Anxiety |
| Patient Depression Questionnaire Scoring | 3 months | 5-\<10 Mild Depression; 10-\<15 Moderate Depression; 15-\<20 Moderately Severe Depression; \>20 Severe Depression |
| Inflammatory Markers | 3 months | TBARS: in fasted (8 hrs) 4.7±0.2 μmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml |
Countries
United States
Outcome results
None listed