Low Calorie Diet in Morbidly Obese Patients

Obesity Clinical Trial

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Official title:

Effect of 6 Days Low Calorie Diet Before Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671279
• Other study ID #: 2015/361
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Low calorie diet
6 days of low calorie diet, estimated kcal 400-600/day.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland
Norway	Haugesund Sjukehus, Helse Fonna	Haugesund

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Fonna

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet		8 days
Secondary	Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet		8 days