Insulin Sensitivity
Conditions
Keywords
Insulin sensitivity, Beta cell function, Carbohydrate preload, Elective hip replacement, Double-blind randomized control study
Brief summary
The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.
Interventions
DIETARY_SUPPLEMENTExperimental: PreOp, NutriciaNordica AB
DIETARY_SUPPLEMENTPlacebo Comparator: Water
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Elective hip replacement
Exclusion criteria
* Known diabetes mellitus * Kidney failure (creatinine clearance \<40 ml/min * Liver failure (aspartate and alanine aminotransferases x 2 above reference) * Hb \<110 g/l * Ongoing severe bacterial or viral infection * Malignancies * Psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity | Morning before surgery and up to two days after surgery | Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Beta Cell Function | Morning before surgery and up to two days after surgery | Beta cell function is measured with intravenous glucose tolerance test (IVGTT) |
Countries
Sweden
Participant flow
Recruitment details
Recruitments between December 2011 and November 2012, at Södersjukhuset, Karlolinska Institutet, Stockholm.
Pre-assignment details
No significant events took part in current studies.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Personal reasons | 1 | 0 |
Baseline characteristics
| Characteristic | Water | PreOp, NutriciaNordica AB | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 4 | 66 years STANDARD_DEVIATION 4 | 67 years STANDARD_DEVIATION 4 |
| Region of Enrollment Sweden | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Change in Insulin Sensitivity
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
Time frame: Morning before surgery and up to two days after surgery
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PreOp, NutriciaNordica AB | Change in Insulin Sensitivity | 3.2 mg/(kg min) | Standard Deviation 2.8 |
| Water | Change in Insulin Sensitivity | 2.4 mg/(kg min) | Standard Deviation 2.6 |
Secondary
Change in Beta Cell Function
Beta cell function is measured with intravenous glucose tolerance test (IVGTT)
Time frame: Morning before surgery and up to two days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PreOp, NutriciaNordica AB | Change in Beta Cell Function | 3.3 Insulin AUC nmol * min/L | Standard Deviation 2.4 |
| Water | Change in Beta Cell Function | 2.6 Insulin AUC nmol * min/L | Standard Deviation 2.2 |