NCT01774084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

January 20, 2013

Results QC Date

April 6, 2014

Last Update Submit

June 3, 2014

Conditions

Insulin Sensitivity

Keywords

Insulin sensitivityBeta cell functionCarbohydrate preloadElective hip replacementDouble-blind randomized control study

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin Sensitivity

    Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp

    Morning before surgery and up to two days after surgery

Secondary Outcomes (1)

  • Change in Beta Cell Function

    Morning before surgery and up to two days after surgery

Study Arms (2)

PreOp, NutriciaNordica AB

ACTIVE COMPARATOR

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

Water

PLACEBO COMPARATOR

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

Interventions

Experimental: PreOp, NutriciaNordica ABDIETARY_SUPPLEMENT
Also known as: PreOp, serial number 27 62 95, NutriciaNordica AB
PreOp, NutriciaNordica AB
Placebo Comparator: WaterDIETARY_SUPPLEMENT
Water

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective hip replacement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Södersjukhuset AB

Stockholm, Sweden, 116 48, Sweden

Location

Södertälje hospital

Södertälje, Södertälje, 15286, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 24007934DERIVED

Related Links

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Thomas Nyström MD, PhD
Organization
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden;
thomas.nystrom@ki.se
+4686163211

Study Officials

  • Thomas Nyström, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 20, 2013

First Posted

January 23, 2013

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

June 5, 2014

Results First Posted

June 5, 2014

Record last verified: 2014-06

Locations

SE(2)