Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

Weight Loss Clinical Trial

Official title:

Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291741
• Other study ID #: 1-16-02-436-21
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: Sigrid B Gribsholt
• Phone: +4561651148
• Email: siggri[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eligible for bariatric surgery

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Very Low Calorie Diet
• Weight Loss

Intervention

Dietary Supplement:
• VLCD
Advice regarding VLCD
• Standard care
Standard dietary advice for weight loss before bariatric surgery

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		8 weeks
Secondary	Patient quality of life measured using the Short Form-12 (SF-12) questionnaire	Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning	8 weeks and 1 year
Secondary	Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose	In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.	30 days after surgery
Secondary	Use of health care services assessed by a medical chart review	We will assess the number of health care contacts for each patient.	30 days after surgery
Secondary	Severity of complications assessed by a medical chart review.	We will define the severity of the contacts based on whether they are outpatient or inpatient contacts.	30 days after surgery
Secondary	Presence of eating disorders	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.	At baseline