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

Primary Purpose

Insulin Sensitivity

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Experimental: PreOp, NutriciaNordica AB

Placebo Comparator: Water

About this trial

This is an interventional treatment trial for Insulin Sensitivity focused on measuring Insulin sensitivity, Beta cell function, Carbohydrate preload, Elective hip replacement, Double-blind randomized control study

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Södersjukhuset AB
Södertälje hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PreOp, NutriciaNordica AB

Water

Arm 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.

Outcomes

Primary Outcome Measures

Change in Insulin Sensitivity

Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp

Secondary Outcome Measures

Change in Beta Cell Function

Beta cell function is measured with intravenous glucose tolerance test (IVGTT)

Full Information

NCT ID

NCT01774084

First Posted

January 20, 2013

Last Updated

June 3, 2014

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01774084

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Sensitivity

Keywords

Insulin sensitivity, Beta cell function, Carbohydrate preload, Elective hip replacement, Double-blind randomized control study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PreOp, NutriciaNordica AB

Arm Type

Active Comparator

Arm Description

Arm Title

Water

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Experimental: PreOp, NutriciaNordica AB

Other Intervention Name(s)

PreOp, serial number 27 62 95, NutriciaNordica AB

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Comparator: Water

Primary Outcome Measure Information:

Title

Change in Insulin Sensitivity

Description

Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp

Time Frame

Morning before surgery and up to two days after surgery

Secondary Outcome Measure Information:

Title

Change in Beta Cell Function

Description

Beta cell function is measured with intravenous glucose tolerance test (IVGTT)

Time Frame

Morning before surgery and up to two days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Nyström, MD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Södersjukhuset AB

City

Stockholm

ZIP/Postal Code

116 48

Country

Sweden

Facility Name

Södertälje hospital

City

Södertälje

ZIP/Postal Code

15286

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24007934

Citation

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.

Results Reference

derived

Links:

URL

http://www-ncbi-nlm-nih-gov.proxy.kib.ki.se/pubmed/24007934

Description

Related Info

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

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