Defining the optimal exercise program to improve glycemic control in type 2 diabetes patients.

For some years, it is obvious that exercise training and medication have
positive influence on lowering insulin sensitivity diabetes type 2 patients
have to cope with. Recently it became possible to measure the effect of the
parameters mentioned above. By Introducing ambulatory continue glucose
measuring, it became possible to evaluate glucose concentrations very precisely
for a 48 hours period.

The application of CGMS offers novel possibilities to define the impact of
different exercise parameters like exercise duration, frequency and intensity
on glycemic control in type 2 diabetes patients. In addition we are interested
in the impact on blood glucose concentrations when glucose or Niaspan® is
ingested just before exercise.


Addendum:
Optimizing and validating the calibration protocols for continuous measurement
of glucose concentrations during exercise with CGM

In order to investigate these questions we therefore propose the following
trials (as described in sections A through E) to assess the efficacy of the
main exercise training modalities to improve glycemic control. The described
studies will provide a clear description of the characteristics of an optimal
exercise intervention program for type 2 diabetes patients.

Intensity High versus low intensity
Sort of exercise duration versus weight training
Frequention Daily versus once every day exercise
Niaspan Exercise with versus exercise without use of Niaspan
Glucose Exercise with versus exercise without use of glucose beverage

Every parameter will be studied with use of 3 trials: During two trial subjects
will perform exercise and in a third trial the subjects will refrain from
exercise (i.e. control trial).

Addendum:
Cross-over study in which the effects of exercise on sensor validity en the
applied calobration protocols will be tested. Every subject will perform 2
tests: exercise and rest

Intensity High versus low intensity training
Sort of exercise duration versus weight training
Frequention Daily versus once every day exercise
Niaspan Exercise with versus exercise without use of Niaspan
Glucose Exercise with versus exercise without use of glucose beverage

All exercise training will be done on a cycle ergo meter, except from
weighttraining. This training uses equipment decribed in section B of the study.

Addendum:
Exercise for 60 min at 50% Wmax

Risks as the result of participation in this experiment are minimal. Estimating
maximum workload capacity in a Wmax test is always done with a physician and MD
present. All Wmax will be done with use of ECG recording for all patients.
Previous studies have shown that wearing the CGMS does not hamper the subject
in his normal functioning. Withholding oral blood glucose lowering medication
for a period of two days does not result in a serious disturbance of blood
glucose homeostasis and blood glucose concentrations will be normalized within
1-2 days after the screening. After the screening, subjects can resume their
normal medication routine. We chose this method because we want to assess the
patients* normal reaction to glucose under normal uncontrolled conditions.

Screening 4 hours
Wearing CGMS 46 hours
Visiting University 5 hours
Exercise intervention 2 hours

Every trial consist of 3 tests, so subjects spent 3 time 50 hour for this
study. In this period of time, they will be visiting the university 15 hours.

Addendum:
Screening 3 hours
testdays 7 hours (on one day 1h of exercise and in the other
day 1h of rest)