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

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Insulin Sensitivity

Treatments: Dietary Supplement: Placebo Comparator: Water; Dietary Supplement: Experimental: PreOp, NutriciaNordica AB

Study type: Interventional

Funder types: Other

Identifiers

NCT01774084

2011/3:6

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

PreOp, NutriciaNordica AB

Active Comparator group

Description:

PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.

Treatment:

Dietary Supplement: Experimental: PreOp, NutriciaNordica AB

Water

Placebo Comparator group

Description:

Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.

Treatment:

Dietary Supplement: Placebo Comparator: Water