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Completed

NCT Number: NCT05291741

Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

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

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Very Low Calorie Diet Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus

Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for bariatric surgery

Exclusion criteria

-

Treatment and study plan

VLCD

Dietary Supplement

Advice regarding VLCD

Standard care

Dietary Supplement

Standard dietary advice for weight loss before bariatric surgery

Primary outcomes

  1. Weight loss

    Time frame: 8 weeks

Secondary outcomes

  1. Patient quality of life measured using the Short Form-12 (SF-12) questionnaire

    Time frame: 8 weeks and 1 year

    Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

  2. Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose

    Time frame: 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.

  3. Use of health care services assessed by a medical chart review

    Time frame: 30 days after surgery

    We will assess the number of health care contacts for each patient.

  4. Severity of complications assessed by a medical chart review.

    Time frame: 30 days after surgery

    We will define the severity of the contacts based on whether they are outpatient or inpatient contacts.

  5. Presence of eating disorders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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