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Completed

NCT Number: NCT01774084

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

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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Key information

Conditions

Insulin Sensitivity Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Södersjukhuset AB, Stockholm, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: PreOp, NutriciaNordica AB

Dietary Supplement

Other names: PreOp, serial number 27 62 95, NutriciaNordica AB

Placebo Comparator: Water

Dietary Supplement

Primary outcomes

  1. Change in Insulin Sensitivity

    Time frame: Morning before surgery and up to two days after surgery

    Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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