Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

Not Applicable

Recruiting

• Conditions: Very Low Calorie Diet; Bariatric Surgery Candidate; Weight Loss
• Interventions: Dietary Supplement: Standard care; Dietary Supplement: VLCD

• Registration Number: NCT05291741
• Lead Sponsor: Aarhus University Hospital

Brief Summary

To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Detailed Description

In this project the investigators want to develop an effective Very Low Calorie Diet (VLCD) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. Thus the investigators will randomize 500 patients to either VLCD or standard care prior to bariatric surgery. The investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-23
• Study Start: 2022-10-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Eligible for bariatric surgery

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Standard care
Very Low Calorie Diet (VLCD)	VLCD	VLCD

Primary Outcome Measures

Name	Time	Method
Weight loss	8 weeks

Secondary Outcome Measures

Name	Time	Method
Presence of eating disorders	At baseline	The patients will be asked to complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess whether diorderes eating is present. Scores range from 0 to 6 and a score of 4 and above indicate disordered eating.
Patient quality of life measured using the Short Form-12 (SF-12) questionnaire	8 weeks and 1 year	Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose	30 days after surgery	In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.
Use of health care services assessed by a medical chart review	30 days after surgery	We will assess the number of health care contacts for each patient.
Severity of complications assessed by a medical chart review.	30 days after surgery	We will define the severity of the contacts based on whether they are outpatient or inpatient contacts.

Trial Locations

Locations (1)

Steno Diabetes Center Aarhus; 🇩🇰 Aarhus, Denmark