¹³C-Methacetin Breath Test (MBT) Methodology Study
Overview
- Phase
- Phase 2
- Intervention
- 13C Methacetin Breath Test
- Conditions
- Healthy Subjects
- Sponsor
- Hadassah Medical Organization
- Locations
- 1
- Last Updated
- 13 years ago
Overview
Brief Summary
Several factors will be tested to see if they have an influence on the methacetin breath test results. Each one of the factors has been raised as a possible source of distortion of the MBT result.
I. Variability between same tests on same subject MBT. Repeatability will be tested in both healthy individuals and patients with chronic liver disease.
II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and can potentially have an effect on the MBT since the breath test is based on CO2 production and these subjects may have abnormal CO2 production.
III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore, internal preliminary data has shown signs that there is an influence of smoking on the MBT ranges.
IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that age is a significant factor in determining the probability of disease severity and preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the effect of age has to be elucidated in an orderly fashion.
V. CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the MBT.
VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results.
VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic blood flow and thereby the outcome of the methacetin breath test.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria - General
- •Adult subjects with 18 years of age or older
- •Women of childbearing potential must have a negative serum or urinary hCG pregnancy test within 7 days prior to enrollment. During the study these women must use 2 methods of contraception.
- •Subject has given written informed consent, prior to any study related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- •Exclusion Criteria - General
- •Severe heart, pulmonary or renal disease.
- •Patient has previous surgical bypass surgery for morbid obesity
- •Patient has extensive small bowel resection
- •Any major surgery in the past 3 months.
- •Patient is a recipient of any organ transplant
Exclusion Criteria
- •Severe heart, pulmonary or renal disease.
- •Patient has previous surgical bypass surgery for morbid obesity
- •Patient has extensive small bowel resection
- •Any major surgery in the past 3 months.
- •Patient is a recipient of any organ transplant
- •Pregnant or breastfeeding women.
- •Patient allergic to acetaminophen
- •Patients who are taking hepatotoxic drugs
- •Patient, based on the opinion of the investigator, should not be enrolled into this study.
- •Patients unable or unwilling to sign informed consent
Arms & Interventions
CYP450 1A2 Inhibitors
Intervention: 13C Methacetin Breath Test
Repeatability
Intervention: 13C Methacetin Breath Test
COPD
Intervention: 13C Methacetin Breath Test
Smokers
Intervention: 13C Methacetin Breath Test
CYP450 1A2 Inhibitors
Intervention: Grape fruit juice
Cirrhosis Beta Blockers
Intervention: 13C Methacetin Breath Test
Cirrhosis Beta Blockers
Intervention: Non selective beta blocker - Propranolol
Alcohol
Intervention: 13C Methacetin Breath Test
Alcohol
Intervention: Ethanol
Outcomes
Primary Outcomes
Not specified