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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01211184
Other study ID # STS1
Secondary ID
Status Completed
Phase N/A
First received September 28, 2010
Last updated June 28, 2013
Start date May 2008
Est. completion date December 2009

Study information

Verified date December 2011
Source Sodertalje Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether fluid or glucose administration before hip replacement surgery minimizes postoperative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism.


Description:

1. How can a simple and safe way to measure the body's tendency to transient diabetes associated with surgery?

2. Can fluid or glucose administration before elective hip surgery, minimizing post-operative muscle breakdown (catabolism), fatigue and disturbances in carbohydrate metabolism?


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria: Patient scheduled for hip surgery. Exclusion Criteria: Endocrinological disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Water administration
patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery.
carbohydrate drink
800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery
Behavioral:
Fasting.
The patient is fasting from midnight before the surgery.

Locations

Country Name City State
Sweden Södertälje Hospital Södertälje

Sponsors (1)

Lead Sponsor Collaborator
Sodertalje Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Insulin Sensitivity (Percent) Insulin sensitivity (micro-mol per kg per minute glucose uptake) was calculated based on an intravenous glucose tolerance test (Theor Biol Med Model 2011, 8: 12) on the day before surgery. The percent change was taken as (day after - day before) / day before Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM). No
Secondary Muscle Catabolism Assessed by the ratio of 3-methylhistidine/creatinine in excreted urine (unit: mmol/mmol).This is an amino acid unique to muscle that does not undergo intermediary metabolism, meaning that its urinary excretion is an index of the degree of muscle catabolism. From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30) No
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