Low Calorie Diet in Morbidly Obese Patients (PreBar)

February 11, 2020 updated by: Haukeland University Hospital

Effect of 6 Days Low Calorie Diet Before Bariatric Surgery

This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.

At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period.

During the operation fatty tissue samples will be taken subcutaneous and from the omentum major.

This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Haugesund, Norway
        • Haugesund Sjukehus, Helse Fonna
    • Hordaland
      • Bergen, Hordaland, Norway, 5020
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 40-46 kg/m2
  • The patients must not conduct a diet before admission.
  • Fasting blood glucose <-7 nmol/l

Exclusion Criteria:

  • Diabetes mellitus
  • Treatment with antidiabetics
  • Allergy for substances in the planned study-diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low calorie diet
Dietary intervention group
Dietary supplement: Low calorie diet
6 days of low calorie diet, estimated kcal 400-600/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Helse Fonna

Investigators

  • Principal Investigator: Gunnar Mellgren, MD, PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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