## Protocol Section
### Identification Module
**NCT ID:** NCT02671279

**Acronym:** PreBar

**Brief Title:** Low Calorie Diet in Morbidly Obese Patients

**Official Title:** Effect of 6 Days Low Calorie Diet Before Bariatric Surgery

#### Organization Study ID Info
**ID:** 2015/361
#### Organization
**Class:** OTHER
**Full Name:** Haukeland University Hospital
### Status Module
#### Completion Date
**Date:** 2019-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-02-13

**Type:** ACTUAL

**Last Update Submit Date:** 2020-02-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-08

**Type:** ACTUAL

#### Start Date
**Date:** 2016-08

**Type:** ACTUAL

**Status Verified Date:** 2017-12

#### Study First Post Date
**Date:** 2016-02-02
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-13
**Study First Submit QC Date:** 2016-01-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Helse Fonna

#### Lead Sponsor

**Class:** OTHER

**Name:** Haukeland University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Obesity

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 15

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dietary intervention group

**Intervention Names:**

- Dietary Supplement: Low calorie diet

**Label:** Low calorie diet

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Low calorie diet

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

**Name:** Low calorie diet

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Measure:** Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet

**Time Frame:** 8 days

#### Secondary Outcomes

**Measure:** Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet

**Time Frame:** 8 days

### Eligibility Module

**Eligibility 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

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bergen

**Country:** Norway

**Facility:** Haukeland University Hospital

**State:** Hordaland

**Zip:** 5020

**Location 2:**

**City:** Haugesund

**Country:** Norway

**Facility:** Haugesund Sjukehus, Helse Fonna

#### Overall Officials

**Official 1:**

**Affiliation:** Haukeland University Hospital

**Name:** Gunnar Mellgren, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
