Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/02/2017
Date assigned
03/04/2017
Last edited
03/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Obesity represents a global epidemic, and increases the risk of developing Type 2 Diabetes Mellitus (T2DM), hence the introduction of the term “diabesity”. The most effective and long-lasting solution for severe obesity is bariatric surgery. Two widely used types of bariatric surgery are gastric bypass and gastric sleeve. Gastric bypass involves re-routing the digestive system past most of the stomach, so less food is digested and it takes much less to feel full. Gastric sleeve involves removing some of the stomach to reduce the amount of food that's required to feel full. Obesity causes changes in the bacteria that live in the gut (microbiota). After bariatric surgery there are changes in the gut microbiota and in intestinal hormones (e.g. GLP-1) that control satiety (fullness) and food intake. Although gut microbiota changes have been suggested to alter levels of GLP-1, the mechanism and its importance in bariatric surgery remain to be determined. The aim of this study is to investigate the changes in the gut microbiota after two different types of bariatric surgery, as well as the relationship with blood levels of GLP-1.

Who can participate?
Women aged 18-65 who are severely obese and not diabetic

What does the study involve?
Participants are randomly allocated into two groups to undergo either gastric bypass or gastric sleeve surgery. Participants are followed for 6 months after surgery, and fecal and blood samples are collected before surgery as well as 3 and 6 months after surgery. Meal-stimulated blood GLP-1 levels are measured before and 3 and 6 months after surgery.

What are the possible benefits and risks of participating?
This study may increase knowledge of the mechanisms controlling obesity and help develop better and less invasive treatments, as well as providing more information regarding the participant’s own outcome of surgery and a more extensive follow-up after surgery. The risks of participating can be considered low as participation only involves repeated blood sampling.

Where is the study run from?
Södertälje Sjukhus AB (Sweden)

When is the study starting and how long is it expected to run for?
February 2017 to February 2018

Who is funding the study?
1. Mats Kleberg Foundation (Sweden)
2. Fredrik och Ingrid Thurings Stiftelse (Sweden)
3. Tore Nilsons Stiftelse för Medicinsk Forskning (Sweden)

Who is the main contact?
Dr Camilla Krizhanovskii

Trial website

Contact information

Type

Scientific

Primary contact

Dr Camilla Krizhanovskii

ORCID ID

http://orcid.org/0000-0003-2195-165X

Contact details

Lagmansvägen 15
Södertälje
15286
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

nr1

Study information

Scientific title

Characterization of the incretin response and microbiota in women before an after bariatric surgery, aiming to determine how the microbiota regulates metabolism, and its role for weight loss: a randomized controlled trial

Acronym

Study hypothesis

Alteration of gut microbiota following bariatric surgery contributes to its efficacy as a weight loss treatment through modulation of the secretion of the anorectic hormone GLP-1.

Ethics approval

Regionala etikprövningsnämnden i Stockholm (regional ethics board in Stockholm), 26/08/2015, ref: 2015/795-31/2

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Obesity

Intervention

Non-diabetic patients with severe obesity (that is, BMI >40 kg/m. or BMI >35 kg/m. with comorbidities) will be randomized into two groups receiving either gastric bypass (RYGB) or gastric sleeve. Patients will be followed for 6 months post-surgery, and fecal and blood samples will be collected before surgery, as well as 3 and 6 months after surgery. Meal stimulated GLP-1 plasma levels will be determined prior to and 3 and 6 months after surgery. The primary endpoint is the proportion of subjects achieving a 15% relative change in meal stimulated GLP-1 plasma levels following gastric bypass surgery (RYGB)/gastric sleeve compared to pre-surgical meal stimulated GLP-1 release, as assessed by GLP-1 specific ELISA of serum samples. Secondary endpoints are whether a 15% weight reduction of presurgical body weight is observed following gastric bypass surgery (RYGB)/sleeve.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Plasma GLP-1, measured using the meal tolerance test and GLP-1 specific ELISA of serum samples
2. Gut microbiota composition, analyzed from fecal samples
Timepoints: before 10-day diet, after 10-day diet/before surgery, 3 months after surgery, 6 months after surgery

Secondary outcome measures

1. Plasma inflammatory markers, analyzed by specific ELISAs
2. Lipid profile, determined by commercially available HDL and LDL/VLDL Cholesterol Assay Kits, Free Fatty Acid Quantification Kit, as well as Triglyceride Quantification Kit

Timepoints: before 10-day diet, after 10-day diet/before surgery, 3 months after surgery, 6 months after surgery

Overall trial start date

27/02/2017

Overall trial end date

27/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obese non-diabetic females
2. 18-65 years of age
3. Signed informed consent form

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30 subjects (15 in each group)

Participant exclusion criteria

1. Type 2 diabetes
2. Any history of receiving GLP-1 analogues or DPP-4 inhibitors
3. Previous treatment with insulin (any regimen) within 3 months
4. Current or history of drug and alcohol abuse

Recruitment start date

27/02/2017

Recruitment end date

27/02/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Södertälje Sjukhus AB
15286
Sweden

Sponsor information

Organisation

Södertälje Sjukhus

Sponsor details

Lagmansvägen 15
Södertälje
15286
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Mats Kleberg Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fredrik och Ingrid Thurings Stiftelse

Alternative name(s)

Fredrik and Ingrid Thurings Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Tore Nilsons Stiftelse för Medicinsk Forskning

Alternative name(s)

Tore Nilsson Foundation, Tore Nilsson Fond

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Camilla Krizhanovskii

Intention to publish date

01/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes