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

June 3, 2014 updated by: Thomas Nystrom, Karolinska Institutet

Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery: A Randomised Doubled-blinded Control Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 116 48
        • Sodersjukhuset AB
      • Södertälje, Sweden, 15286
        • Södertälje Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insulin Sensitivity
Time Frame: Morning before surgery and up to two days after surgery
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
Morning before surgery and up to two days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Morning before surgery and up to two days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Thomas Nyström, MD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 20, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/3:6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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