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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreOp, NutriciaNordica AB | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: PreOp, NutriciaNordica AB | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Sensitivity | Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp | Morning before surgery and up to two days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beta Cell Function | Beta cell function is measured with intravenous glucose tolerance test (IVGTT) | Morning before surgery and up to two days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Nyström, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset AB | Stockholm | Sweden | 116 48 | Sweden | ||
| Södertälje hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24007934 | Derived | Ljunggren S, Hahn RG, Nystrom T. Insulin sensitivity and beta-cell function after carbohydrate oral loading in hip replacement surgery: a double-blind, randomised controlled clinical trial. Clin Nutr. 2014 Jun;33(3):392-8. doi: 10.1016/j.clnu.2013.08.003. Epub 2013 Aug 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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No significant events took part in current studies.
Recruitments between December 2011 and November 2012, at Södersjukhuset, Karlolinska Institutet, Stockholm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Water |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Insulin Sensitivity | Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp | Per protocol | Posted | Mean | Standard Deviation | mg/(kg min) | Morning before surgery and up to two days after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Nyström MD, PhD | Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden; | +4686163211 | thomas.nystrom@ki.se |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo Comparator: Water | Dietary Supplement |
|
| Södertälje |
| Södertälje |
| 15286 |
| Sweden |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Beta Cell Function | Beta cell function is measured with intravenous glucose tolerance test (IVGTT) | Posted | Mean | Standard Deviation | Insulin AUC nmol * min/L | Morning before surgery and up to two days after surgery |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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. | 0 | 12 | 0 | 12 |
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