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Completed

NCT Number: NCT02671279

Low Calorie Diet in Morbidly Obese Patients

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Hordaland, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Low calorie diet

Dietary Supplement

6 days of low calorie diet, estimated kcal 400-600/day.

Primary outcomes

  1. Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet

    Time frame: 8 days

Secondary outcomes

  1. Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Fonna

Registry information

Official study title

Effect of 6 Days Low Calorie Diet Before Bariatric Surgery

Acronym: PreBar

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 2, 2016
Registry last updated
Feb 13, 2020

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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