Low Calorie Diet in Morbidly Obese Patients

NCT ID: NCT02671279

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low calorie diet

Dietary intervention group

Group Type OTHER

Low calorie diet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Low calorie diet

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Fonna

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Mellgren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, Hordaland, Norway

Site Status

Haugesund Sjukehus, Helse Fonna

Haugesund, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2015/361

Identifier Type: -

Identifier Source: org_study_id

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