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Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery

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ClinicalTrials.gov Identifier: NCT01774084
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas Nystrom, Karolinska Institutet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Insulin Sensitivity
Interventions Dietary Supplement: Experimental: PreOp, NutriciaNordica AB
Dietary Supplement: Placebo Comparator: Water
Enrollment 23
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.
Arm/Group Title PreOp, NutriciaNordica AB Water
Hide Arm/Group Description 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: 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.
Period Title: Overall Study
Started 11 12
Completed 10 12
Not Completed 1 0
Reason Not Completed
Personal reasons             1             0
Arm/Group Title PreOp, NutriciaNordica AB Water Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
10
  83.3%
19
  86.4%
>=65 years
1
  10.0%
2
  16.7%
3
  13.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 22 participants
66  (4) 68  (4) 67  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
7
  70.0%
8
  66.7%
15
  68.2%
Male
3
  30.0%
4
  33.3%
7
  31.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Change in Insulin Sensitivity
Hide Description Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
Time Frame Morning before surgery and up to two days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title PreOp, NutriciaNordica AB Water
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: mg/(kg min)
3.2  (2.8) 2.4  (2.6)
2.Secondary Outcome
Title Change in Beta Cell Function
Hide Description Beta cell function is measured with intravenous glucose tolerance test (IVGTT)
Time Frame Morning before surgery and up to two days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PreOp, NutriciaNordica AB Water
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: Insulin AUC nmol * min/L
3.3  (2.4) 2.6  (2.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PreOp, NutriciaNordica AB Water
Hide Arm/Group Description 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: 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.
All-Cause Mortality
PreOp, NutriciaNordica AB Water
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PreOp, NutriciaNordica AB Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PreOp, NutriciaNordica AB Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Thomas Nyström MD, PhD
Organization: Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden;
Phone: +4686163211
Responsible Party: Thomas Nystrom, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01774084     History of Changes
Other Study ID Numbers: 2011/3:6
First Submitted: January 20, 2013
First Posted: January 23, 2013
Results First Submitted: April 6, 2014
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014