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NCT01774084 Clinical Trial

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

Insulin Sensitivity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01774084
Other study ID # 2011/3:6
Secondary ID
Status Completed
Phase Phase 4
First received January 20, 2013
Last updated June 3, 2014
Start date January 2012
Est. completion date March 2013

Study information
Verified date June 2014
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Experimental: PreOp, NutriciaNordica AB

• Placebo Comparator: Water

Locations
Country Name City State
Sweden Södertälje hospital Södertälje
Sweden Södersjukhuset AB Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Insulin Sensitivity Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp Morning before surgery and up to two days after surgery No
Secondary Change in Beta Cell Function Beta cell function is measured with intravenous glucose tolerance test (IVGTT) Morning before surgery and up to two days after surgery No
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