Increasing habitual physical activity to reduce the surgical risk of hyperglycemia and complications in patients with the metabolic syndrome

Increasing habitual physical activity to reduce the surgical risk of hyperglycemia and complications in patients with the metabolic syndrome - POSitive II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39014

Enrollment

582

Registered

2013-02-27

Start date

2013-05-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome prediabetes

Interventions

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 accelerome

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The effect of the POSitive program will be measured as the incidence of perioperative hyperglycemia in the intervention group when compared to controls.	—

Secondary

Measure	Time frame
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 ( 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	—

Measure

Time frame

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 ( 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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)