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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Experimental: PreOp, NutriciaNordica AB

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Water

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Experimental: PreOp, NutriciaNordica AB

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator: Water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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PreOp, serial number 27 62 95, NutriciaNordica AB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes