Preoperative Carbohydrate Loading in Bariatric Surgery

Medical University of Gdansk

Status and phase: Unknown; Phase 4

Conditions: Obesity, Morbid

Treatments: Dietary Supplement: Nutricia PreOp

Study type: Interventional

Funder types: Other

Identifiers

NCT04486079

PreOpxBariatric

Details and patient eligibility

About

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obtaining written and informed patient consent.
• No medical contraindications to perform a bariatric operation
• No contraindications for the use of a rich carbohydrate drink

Exclusion criteria

• No consent to participate in the study
• Age under 18 years
• The intolerance of the carbohydrate drink used in the test
• The contraindications to perform bioimpedance measurements of body composition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Carbohyrate loading

Experimental group

Description:

Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.

Treatment:

Dietary Supplement: Nutricia PreOp

Fasting

No Intervention group

Description:

Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.