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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Nystrom, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01774084
First received: January 20, 2013
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  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 Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change in insulin sensitivity [ Time Frame: Morning before surgery and up to two days after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas Nystrom, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01774084     History of Changes
Other Study ID Numbers: 2011/3:6
Study First Received: January 20, 2013
Last Updated: March 25, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013