Phase 4
N=23
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery
Insulin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01774084 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Change in Insulin Sensitivity — 3.2; 2.4 mg/(kg min)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Experimental: PreOp, NutriciaNordica AB (Dietary_supplement); Placebo Comparator: Water (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Sensitivity |
3.2; 2.4 | — |
| SECONDARY Change in Beta Cell Function |
3.3; 2.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01774084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.