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

Phase 4

Completed

• Conditions: Insulin Sensitivity

• Registration Number: NCT01774084
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-01-20
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-23
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Results First Submitted: 2014-04-06
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-03
• Results First Posted: 2014-06-05
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Insulin Sensitivity	Morning before surgery and up to two days after surgery	Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp

Secondary Outcome Measures

Name	Time	Method
Change in Beta Cell Function	Morning before surgery and up to two days after surgery	Beta cell function is measured with intravenous glucose tolerance test (IVGTT)

Trial Locations

Locations (2)

Södertälje hospital; 🇸🇪 Södertälje, Sweden

Södersjukhuset AB; 🇸🇪 Stockholm, Sweden