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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774084
First Posted: January 23, 2013
Last Update Posted: June 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Nystrom, Karolinska Institutet
  Purpose
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.

Condition Intervention Phase
Insulin Sensitivity Dietary Supplement: Experimental: PreOp, NutriciaNordica AB Dietary Supplement: Placebo Comparator: Water Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery: A Randomised Doubled-blinded Control Study

Resource links provided by NLM:


Further study details as provided by Thomas Nystrom, Karolinska Institutet:

Primary Outcome Measures:
  • Change in Insulin Sensitivity [ Time Frame: Morning before surgery and up to two days after surgery ]
    Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp


Secondary Outcome Measures:
  • Change in Beta Cell Function [ Time Frame: Morning before surgery and up to two days after surgery ]
    Beta cell function is measured with intravenous glucose tolerance test (IVGTT)


Enrollment: 23
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Dietary Supplement: Experimental: PreOp, NutriciaNordica AB
Other Name: PreOp, serial number 27 62 95, NutriciaNordica AB
Placebo Comparator: 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.
Dietary Supplement: Placebo Comparator: Water

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774084


Locations
Sweden
Södersjukhuset AB
Stockholm, Sweden, 116 48
Södertälje hospital
Södertälje, Sweden, 15286
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Thomas Nyström, MD Karolinska Institutet
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Nystrom, MD, 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
Last Verified: June 2014

Keywords provided by Thomas Nystrom, Karolinska Institutet:
Insulin sensitivity
Beta cell function
Carbohydrate preload
Elective hip replacement
Double-blind randomized control study

Additional relevant MeSH terms:
Hypersensitivity
Insulin Resistance
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs