The primary objective of this study is to investigate whether skeletal muscle glucose metabolism, perioperative glucose control and hemodynamics are affected by increasing physical activity in the weeks preceding surgery in patients identified with…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in muscular GLUT-4 expression after increased physical activity
Secondary outcome
*Changes in physical activity during lifestyle intervention (daily steps taken)
*Influence of increased physical activity on perioperative glucose control
(measured as longitudinal plasma glucose levels during surgery)
*Influence of increased physical activity on perioperative hemodynamics.
Influence of increased physical activity on heart rate variability
Background summary
Health risk assessment by an anesthesiologist in the weeks preceding surgery is
elaborated to identify patients at risk for perioperative complications. This
assessment further enables individualized perioperative management that aims at
optimizing the health condition of the patient. The majority of patients suffer
from acquired health risk factors, which may additionally contribute to
impaired skeletal muscle glucose and fatty acid metabolism, GLUT-4 protein
expression, disturbed perioperative glucose control and hemodynamics. It has
been shown that augmentation of physical activity may be beneficial for
muscular GLUT-4 expression, but it is unknown whether this may additionally
result in improved perioperative control of glucose and hemodynamics. Here we
aim to investigate whether structural exercise in the six weeks preceding
surgery may contribute to improvement of the metabolic and hemodynamic profile
of surgical patients.
Study objective
The primary objective of this study is to investigate whether skeletal muscle
glucose metabolism, perioperative glucose control and hemodynamics are affected
by increasing physical activity in the weeks preceding surgery in patients
identified with two or more acquired health risk factors and impaired glucose
tolerance (IGT).
Study design
Prospective, single center intervention study
Intervention
Patients are stimulated to increase their daily physical activity by increasing
daily steps taken for a minimum of 6 consecutive weeks
Study burden and risks
Site visits: A total of three additional site visits, one additional
questionnaire and three additional blood samples by vena puncture on top of
regular practice will be required to collect all data.
Metabolism: Determination of fasting plasma glucose (FPG) and oral glucose
tolerance test (OGTT) after overnight fasting requires extra blood sampling.
Physical condition: Patients perform a 6 minute walk distance test (6MWD)
during the preoperative assessment and the day before surgery.
GLUT-4 expression: Two muscle biopsies will be taken, the first in the
preoperative assessment phase under local anesthesia, the second after
anesthesia induction. The muscle biopsies may cause a muscle hematoma. An
experience investigator will be asked to perform the muscle biopsy to reduce
the risk for muscle hemotoma.
Physical activity: patients will increase their physical activity for 6 weeks,
which is recorded by a pedometer and in a diary.
Although the burden for the patient is substantial and there are mild risks
associated with participation in this study, we believe these outweigh the
benefits for the individual patient and the patient population as a whole.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
The patient has at least two of the following lifestyle risk factors:
- Overweight (BMI >25 kg/m2)
- Hypertension (systolic blood pressure>140 mmHg and/or diastolic blood pressure>90 mmHg)
- Physical inactivity (< 30 min/day of moderate activity, like walking or cycling)
In combination with: Newly identified impaired glucose tolerance;General inclusion criteria
* Newly identified impaired glucose tolerance (IGT)
* Age between 40 and 75 years
* Undergoing elective surgery not sooner than 8 weeks after the PAOC visit
* Non-cardivascular surgery with a minimal duration of 60 minutes
* ASA class I-III
* Able to walk independent of assistance
* Signed informed consent
Exclusion criteria
- Prior diagnosis of diabetes mellitus
- Not fit enough to participate in this study
- ASA class IV
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35180.029.10 |