The primary objective is to investigate whether insulin sensitivity can be preserved postoperatively, by giving a simple carbohydrate-rich drink before surgery. Furthermore, to investigate whether gastric passage will be enhanced postoperatively…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters of the study are insulin resistance.
Secondary outcome
Secondary parameters will be gastric emptying rate hormone levels and well
being.
Background summary
Fasting before surgery has a large effect on the postoperative condition of the
patient. Surgical trauma decreases insulin sensitivity postoperatively. This
loss of insulin sensitivity is enhanced when patients are in a fasted state
before operation. Furthermore, surgical trauma influences postoperative gastric
motility. Patients often feel distressed, experience nausea and vomiting.
Fasting before surgery may enhance a delayed restart of normal gastric
motility. A preoperative drink may reduce this and instead promote an earlier
onset of normal gastric motility.
Study objective
The primary objective is to investigate whether insulin sensitivity can be
preserved postoperatively, by giving a simple carbohydrate-rich drink before
surgery. Furthermore, to investigate whether gastric passage will be enhanced
postoperatively when given a preoperative carbohydrate load. Secondary, gastric
hormones will be determined to investigate changes after surgery when given a
preoperative carbohydrate-rich drink. Furthermore, the well being of the
patient will be investigated all of the groups.
Study design
A double blind, placebo controlled intervention study at the department of
orthopedics of the VU medical center, Amsterdam.
Inclusion criteria:
-in need of hipreplacement
-intact mental status
-BMI: 20-25 kg/m2
-stable weight within the previous 3 months
-having obtained his/her informed consent
Exclusion criteria:
-Diabetes Mellitus
-Sliding hiatal hernia
-Paraesophageal hiatal hernia
-Obstruction gastrointestinal tract
-Use of certain medication: thyroid medication, corticosteroids, diuretic
medication, antiemetics, antihypertensive medication
-Patients participating in another trial
Intervention
Either one of two carbohydrate-rich drinks or a placebo will be given 3 hours
preoperatively. In a subgroup (group B), a gastric emptying scintigraphy will
be made before and after surgery. Blood samples will be taken to investigate
insulin sensitivity and gastric hormonal changes.
Study burden and risks
The possible benefit of the study is related to the effect of a preoperative
carbohydrate load. Oral administration of a carbohydrate-rich drink before
surgery can reduce postoperative insulin resistance and may preserve gastric
emptying rates. Research showed that both of the drinks can be safely
administered to humans and no adverse effects are reported. Part of the
patients will undergo a gastric emptying scintigraphy before and after
operation. This is an adequate and safe method to measure gastric passage.
postbus 7057
1007 MB Amsterdam
Nederland
postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Due for elective hip or knee surgery
- Intact mental status
- BMI: 20-25 kg/m2
- Stable weight last three months
- Having obtained his/her informed consent
Exclusion criteria
- Diabetes mellitus patients
- Sliding hiatal hernia
- Paraesophageal hiatal hernia
- Obstruction gastrointestinal tract
- Use of certain medication: thyroid medication, corticosteroids, diuretic medication, antihypertensive medication, antiemetica
- Patients participating in another trial
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 | NL19429.029.07 |