NCT02671279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 13, 2020

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

July 13, 2015

Last Update Submit

February 11, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

    8 days

Secondary Outcomes (1)

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

    8 days

Study Arms (1)

Low calorie diet

OTHER

Dietary intervention group

Dietary Supplement: Low calorie diet

Interventions

Low calorie dietDIETARY_SUPPLEMENT

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

Low calorie diet

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 40-46 kg/m2
  • The patients must not conduct a diet before admission.
  • Fasting blood glucose \<-7 nmol/l

You may not qualify if:

  • Diabetes mellitus
  • Treatment with antidiabetics
  • Allergy for substances in the planned study-diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital

Bergen, Hordaland, 5020, Norway

Location

Haugesund Sjukehus, Helse Fonna

Haugesund, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Gunnar Mellgren, MD, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

February 2, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2019

Last Updated

February 13, 2020

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)