Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rush University Medical Center
With
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
There are 4 different categories of participants that were used for recruitment:
Healthy controls
Subjects must have a normal physical exam
No GI complaints
No known liver disease
Normal liver function tests (ALT, AST, bilirubin, alkaline phosphatase, serum albumin)
Consume no more than a moderate amount of alcohol (NIAAA definition \[1 \]).
These subjects should not be daily drinkers (\< 3x / week) and should typically drink \< 3 drinks per occasion.
Alcoholics
Subjects should fulfill NIAAA criteria for at-risk drinking \& alcohol abuse or dependence \& DSM-IV criteria for alcoholism
Each must have consumed alcohol regularly for at least the past 3 mos but must be sober for 3-7 day post-binge at the time of sugar test (except for group 7)
Have a total regular heavy drinking history of at least 10 y (except for Group 6) the minimal period of time required for the development of ALD.
ALCOHOLICS WITHOUT LIVER DISEASE
no clinical evidence of ALD on physical examination
serum bilirubin or ALT or AST less than 1.25X normal
sobriety must be \<7 days at the time of sugar test.
ALCOHOLICS WITH LIVER DISEASE
These subjects will have 1 of 3 possible grades of LD severity (mild, moderate, severe) \& have either clinical evidence of LD (hepatomegaly, splenomegaly, and esophageal varices), or serum bilirubin or ALT or AST more than 1.5X normal.
If liver biopsy or CT or ultrasound is available, there should be histological evidence of LD (alcoholic hepatitis or cirrhosis) or radiological evidence of LD (cirrhotic liver, splenomegaly, varices)
Their sobriety must be \<7 days at the time of the sugar test.
ALCOHOLICS WITH SHORT-TERM Drinking
These subjects should fulfill the criteria of alcohol abuse
have sobriety \<7 days at the time of urine collection, but the duration of their heavy drinking must be \<5 years
They must not have any liver disease (negative serology) due to non-EtOH causes or clinical evidence of
You may not be if
SOBER ALCOHOLICS WITH LD .
Criteria is the same as Alcholics with liver disease but last drink was \>7 days from the study enrollment.
Subjects with Non-alcoholic liver disease
Criteria for LD are similar to those outlined for alcoholics with liver disease subjects except that drinking history should be similar to that of healthy volunteers. Subjects after liver transplant.
These subjects must have successful liver transplantation at least 6 mos prior to the study and are on stable doses of immunosuppression for 3 mos.
Unreliable drinking history (to rule out closet drinkers or pretenders).
Subjects must clearly fulfill the criteria either of "alcoholism" or of "on-drinker".
Subjects with a drinking history of 5-9 years duration are excluded since this period is not short enough to preclude cirrhosis nor long enough to cause ALD in most subjects.
