Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

NCT ID: NCT05291741

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate Very Low Calorie Diet Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Very Low Calorie Diet (VLCD)

VLCD

Group Type ACTIVE_COMPARATOR

VLCD

Intervention Type DIETARY_SUPPLEMENT

Advice regarding VLCD

Standard care

Standard care

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type DIETARY_SUPPLEMENT

Standard dietary advice for weight loss before bariatric surgery

Interventions

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VLCD

Advice regarding VLCD

Intervention Type DIETARY_SUPPLEMENT

Standard care

Standard dietary advice for weight loss before bariatric surgery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Eligible for bariatric surgery

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Steno Diabetes Center Aarhus

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sigrid B Gribsholt

Role: CONTACT

+4561651148

Facility Contacts

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Sigrid B Gribsholt

Role: primary

Other Identifiers

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1-16-02-436-21

Identifier Type: -

Identifier Source: org_study_id

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