Trial Outcomes & Findings for Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery (NCT NCT01774084)
NCT ID: NCT01774084
Last Updated: 2014-06-05
Results Overview
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Morning before surgery and up to two days after surgery
Results posted on
2014-06-05
Participant Flow
Recruitments between December 2011 and November 2012, at Södersjukhuset, Karlolinska Institutet, Stockholm.
No significant events took part in current studies.
Participant milestones
| Measure |
PreOp, NutriciaNordica AB
PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
Water
Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
PreOp, NutriciaNordica AB
PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
Water
Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
|---|---|---|
|
Overall Study
Personal reasons
|
1
|
0
|
Baseline Characteristics
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery
Baseline characteristics by cohort
| Measure |
PreOp, NutriciaNordica AB
n=10 Participants
PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
Water
n=12 Participants
Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 4 • n=93 Participants
|
68 years
STANDARD_DEVIATION 4 • n=4 Participants
|
67 years
STANDARD_DEVIATION 4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=93 Participants
|
12 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Morning before surgery and up to two days after surgeryPopulation: Per protocol
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
Outcome measures
| Measure |
PreOp, NutriciaNordica AB
n=10 Participants
PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
Water
n=12 Participants
Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
|---|---|---|
|
Change in Insulin Sensitivity
|
3.2 mg/(kg min)
Standard Deviation 2.8
|
2.4 mg/(kg min)
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Morning before surgery and up to two days after surgeryBeta cell function is measured with intravenous glucose tolerance test (IVGTT)
Outcome measures
| Measure |
PreOp, NutriciaNordica AB
n=10 Participants
PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
Water
n=12 Participants
Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
|
|---|---|---|
|
Change in Beta Cell Function
|
3.3 Insulin AUC nmol * min/L
Standard Deviation 2.4 • Interval 2.3 to 3.3
|
2.6 Insulin AUC nmol * min/L
Standard Deviation 2.2 • Interval 1.7 to 6.4
|
Adverse Events
PreOp, NutriciaNordica AB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Nyström MD, PhD
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden;
Phone: +4686163211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place