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
Verified date | June 2014 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Södertälje hospital | Södertälje | |
Sweden | Södersjukhuset AB | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
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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