cookies, and desserts. Advice to increase
daily physical activity was also given. The
patients completed weighed dietary
records by describing and weighing all
food and beverages that were consumed
for 3 consecutive days 1 month and 1 year
after the VLED. The study medication returned
by the patients at clinic visits was
counted.
If glucose control deteriorated in patients
with type 2 diabetes, metformin
was started according to a predetermined
plan. If the A1C level exceeded 10% after
maximal metformin treatment (2 g daily),
the subject should be withdrawn from the
study. Medication for high blood pressure
was allowed. At inclusion, lipid-lowering
drugs were not allowed but treatment
with statins for hyperlipidemia was allowed,
if deemed necessary according to
the judgment of the investigator. Almost
two-thirds of the randomized participants
(200 of 309) completed the 3-year study.
The body weight (with a calibrated
scale at each center and with the patients
in underwear without shoes), waist circumference
(measured midway between
lower costa and crista), and blood pressure
were determined. Adverse events
and changes of medication were recorded
at every visit. Fasting plasma glucose; insulin;
C-peptide; A1C; total, HDL, and
LDL cholesterol; and triglycerides were
measured at a certified central laboratory
(Medi-Lab, Copenhagen, Denmark).