In the POSitive project we aim to investigate whether the diagnosis of the metabolic syndrome could be embedded in the clinical practice of the POS. The use of the POS clinic as screening platform for health prevention contributes to early case…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of the POSitive program will be measured as the incidence of
perioperative hyperglycemia in the intervention group when compared to
controls.
Secondary outcome
Intervention endpoints:
- Change in daily steps taken
Health condition endpoints:
- Change in body mass index
- Change in waist circumference
- Change in blood pressure
- Change in fasting blood glucose
- Change in fasting blood lipid levels
- Change in aerobic fitness measured by the VO2 max
- Change in fat free mass and percentage total body fat
Condition endpoint:
- Number of patients with a normal fasting blood glucose (< 6.1 mmol/l) but
with impaired glucose tolerance measured using an oral glucose tolerance test
(OGTT; blood glucose > 7.8 mmol/l at 2-hours after ingestion of a glucose load).
Surgery-related endpoints:
- Perioperative use of insulin
- Number of perioperative and postoperative complications (infections, use of
antibiotics, renal impairment, cardiac arrhythmia and myocardial ischemia)
- Length of hospital stay
Postoperative endpoints:
- Health condition and use of health care facilities after 2 weeks following
surgery.
- Assessment of physical activity level by a questionnaire at 6 months
following surgery.
Population endpoints that may influence the effect of the POSitive program:
- Use of statins or antidiabetic drugs
- Age
- Ethnical background
- Socioeconomic status
Background summary
About 15% of the general adult patient population visiting the Preoperative
Screening (POS) outpatient clinic for a routine preoperative health risk
assessment by an anesthesiologist is diagnosed with central obesity. Although
about 35% of these patients silently suffer from the metabolic syndrome, most
patients leave the POS clinic without an appropriate diagnosis of their
cardiometabolic state.
In addition to the latent risk of an undiagnosed metabolic syndrome for the
development of cardiovascular disease and diabetes, cardiometabolic
derangements may become abundant during stressful events like anesthesia and
surgery, leading to perioperative hyperglycemia. Perioperative hyperglycemia is
a well-known predictor for postoperative complications like infections and a
prolonged hospital stay. Despite the tangible, but undiagnosed presence of the
metabolic syndrome in the surgical population, the POS clinic is not considered
as screening platform for cardiometabolic disease and the implementation of
preventive interventions.
Study objective
In the POSitive project we aim to investigate whether the diagnosis of the
metabolic syndrome could be embedded in the clinical practice of the POS. The
use of the POS clinic as screening platform for health prevention contributes
to early case finding of the metabolic syndrome in surgical patients. We
further aim to implement the POSitive habitual physical activity program in
patients who are diagnosed with the metabolic syndrome in the weeks preceding
surgery in order to improve the health condition of these patients, and reduce
the risk for perioperative hyperglycemia. We hypothesize that the POS setting
is an effective platform for new onset diagnosis of the metabolic syndrome and
the institution of a habitual activity lifestyle program.
Study design
Screening of about 1700 patients at the POS for central obesity and a HbA1c >
5.5% with or without mild-severe hypertension (niet-WMO part).
In the presence of the metabolic syndrome, patients will be randomized into a
control arm (passive lifestyle advice, visit general practitioner) or the
POSitive intervention arm (active lifestyle advice based on the individual
needs, coaching, visit general practitioner). Patients will follow the
intervention until the day of surgery (WMO part).
Intervention
Control group
Patients in the control group are not subjected to the daily habitual physical
activity intervention and do not receive telephone coaching. Daily activity is
measured by an accelerometer with a one-week memory function, which is blinded
for the participant.
POSitive program group
The POSitive program promotes an increase in habitual physical activity in
patients diagnosed with new onset metabolic syndrome. Patients receive a
pedometer. This program consists of the following components:
- Increasing awareness of an unhealthy lifestyle (risk communication)
- Offering of practical lifestyle improvement solutions to show the
changeability of the physical health state
- Tailor-made action plans to increase daily habitual physical activity
Study burden and risks
The present study is primarily developed to show that many patients silently
suffer from cardiometabolic disease. Using the POS as screening platform we may
not only detect de novo prediabetes/diabetes, but may additionally off passive
lifestyle advice (control group) or active lifestyle coaching (POSitive group)
to prevent further development of cardiometabolic disease and the development
of intraoperative hyperglycemia. The burden and risks that are associated with
the study is, to our opinion, acceptable in light of the possible health
benefits for the patients on the long run.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Abdominal weight circumference of >= 102 cm in males and >= 88 cm in females
Patients who are able to increase their habitual physical activity levels.
A HbA1c > 5.5%
Age 18-80 years
Elective non-cardiac surgery with a waiting time of > 5 weeks
Exclusion criteria
Existing diabetes mellitus type 1/2
Diagnosis of type 2 diabetes mellitus during the POSitive program screening (blood glucose > 11 mmol/l at 2 hours following a glucose load). New onset diagnosis of type 2 diabetes mellitus needs confirmation by a general practitioner.
Myocardial ischemic disease
Patients with disabilities that prohibit an increase in habitual physical activity due to muscular or orthopedic disorders.
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 | NL42863.029.12 |