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The effect of a preoperative lifestyle intervention in patients with acquired risk factors on perioperative glucose control and hemodynamics.


- candidate number10313
- NTR NumberNTR3057
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2011
- Secondary IDs2010/381 MEC VUmc
- Public TitleThe effect of a preoperative lifestyle intervention in patients with acquired risk factors on perioperative glucose control and hemodynamics.
- Scientific TitleThe effect of a preoperative lifestyle intervention in patients with acquired risk factors on perioperative glucose control and hemodynamics.
- ACRONYMPOSitive study
- hypothesisA preoperative exercise intervention of six weeks improves glucose tolerance, skeletal muscle GLUT-4 protein expression, perioperative glucose regulation and intraoperative hemodynamics in patients with aquired risk factors and impaired glucose tolerance (IGT).
- Healt Condition(s) or Problem(s) studiedObesity, Hypertension, Risk factors, Impaired glucose tolerance (IGT) , Inactivity, Dyslipemia
- Inclusion criteriaAt least two out of following risk factors:
1. Obesity (BMI >30 kg/m2);
2. Hypertension (>140 mmHg systolic and/or >90 mmHg diastolic);
3. Physical inactivity (< 30 min/day of moderate activity, like walking or cycling).
And:
4. Newly identified impaired glucose tolerance (IGT);
5. Age between 40 and 65 years;
6. Undergoing elective surgery not sooner than 8 weeks after the PAOC visit;
7. Abdominal/urological surgery;
8. ASA class I-III;
9. Able to walk independent of assistance.
- Exclusion criteria1. Prior diagnosis of diabetes mellitus;
2. Anti-hypertensive therapy;
3. Cardiovascular co-morbidity;
4. Not fit enough to participate in this study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-apr-2012
- Target number of participants40
- InterventionsPatients in the intervention group are stimulated to increase their daily physical activity by increasing daily steps taken for a minimum of 6 consecutive weeks. Our aim is to meet the WHO guideline advising physical activity of moderate-intensity during 30 min at least 5 days a week and motivate patients with a sedentary lifestyle (<5.000 steps/day) to increase their daily activity to the definition of an active lifestyle (10.000-12.000 steps/day) according to well established pedometer-determined cut-off points by Tudor-Locke and Bassett Jr. Patients in the control group are not subjected to the exercise intervention.
- Primary outcomeChanges in muscular GLUT-4 expression, intracellular Akt phosphorylation and glucose tolerance after a defined increase in physical activity in the 6 weeks before surgery.
- Secondary outcome1. Changes in physical activity during lifestyle intervention (WHO guideline, daily steps taken);
2. Influence of increased physical activity on perioperative glucose control (measured as longitudinal plasma glucose levels during surgery);
3. Influence of increased physical activity on perioperative hemodynamics (changes in heart rate and blood pressure during surgery);
4. Other changes in muscle cell that can possibly quantify increased physical activity (glycogen accumulation and fatty acid metabolism).
- Timepoints(t=day 1): Baseline (pre-intervcention) measurement;
(t=wk 1-6): Self-monitoring of daily physical activity (pedomter+diary);
(t=wk 6): Post interventional measurement;
(t=end of week 6): Intra-operative measurement, during surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Christa Boer
- CONTACT for SCIENTIFIC QUERIESDr. Katrin Stoecklein
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-sep-2011 - 18-sep-2011


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