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Low Calorie Diet in Morbidly Obese Patients (PreBar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671279
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Helse Fonna
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Low calorie diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of 6 Days Low Calorie Diet Before Bariatric Surgery
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : December 2019

Arm Intervention/treatment
Low calorie diet
Dietary intervention group
Dietary Supplement: Low calorie diet
6 days of low calorie diet, estimated kcal 400-600/day.




Primary Outcome Measures :
  1. Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671279


Locations
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Norway
Haukeland University Hospital
Bergen, Hordaland, Norway, 5020
Haugesund Sjukehus, Helse Fonna
Haugesund, Norway
Sponsors and Collaborators
Haukeland University Hospital
Helse Fonna
Investigators
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Principal Investigator: Gunnar Mellgren, MD, PhD Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02671279    
Other Study ID Numbers: 2015/361
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No