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Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Very Low Calorie Diet, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
VLCD
Standard care
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible for bariatric surgery

Exclusion Criteria:

-

Sites / Locations

  • Steno Diabetes Center AarhusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Very Low Calorie Diet (VLCD)

Standard care

Arm Description

VLCD

Standard care

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

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
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.
Use of health care services assessed by a medical chart review
We will assess the number of health care contacts for each patient.
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.
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.

Full Information

First Posted
February 21, 2022
Last Updated
May 10, 2023
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05291741
Brief Title
Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
Official Title
Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Very Low Calorie Diet, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very Low Calorie Diet (VLCD)
Arm Type
Active Comparator
Arm Description
VLCD
Arm Title
Standard care
Arm Type
Placebo Comparator
Arm Description
Standard care
Intervention Type
Dietary Supplement
Intervention Name(s)
VLCD
Intervention Description
Advice regarding VLCD
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard care
Intervention Description
Standard dietary advice for weight loss before bariatric surgery
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient quality of life measured using the Short Form-12 (SF-12) questionnaire
Description
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time Frame
8 weeks and 1 year
Title
Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose
Description
In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.
Time Frame
30 days after surgery
Title
Use of health care services assessed by a medical chart review
Description
We will assess the number of health care contacts for each patient.
Time Frame
30 days after surgery
Title
Severity of complications assessed by a medical chart review.
Description
We will define the severity of the contacts based on whether they are outpatient or inpatient contacts.
Time Frame
30 days after surgery
Title
Presence of eating disorders
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible for bariatric surgery Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigrid B Gribsholt
Phone
+4561651148
Email
siggri@rm.dk
Facility Information:
Facility Name
Steno Diabetes Center Aarhus
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigrid B Gribsholt

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

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