Physiological Effects of Gastric Sleeve Operation

November 25, 2020 updated by: Maria Saur Svane, Hvidovre University Hospital

Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass

After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Please Select
      • Hvidovre, Please Select, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation > 12 month prior to inclusion.

Matched un-operated control subjects.

Description

SG ang RYGB group:

Inclusion Criteria:

  • Uncomplicated RYGB or SG > 12 month prior to inclusion
  • Weight stable (+/- 3 month the last month)
  • Written informed consent

Exclusion Criteria:

  • Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
  • Pregnancy and/or breastfeeding
  • Inadequately treated thyroid disease
  • Serious heart or respiratory illness
  • Haemoglobin < 6,5 mM.

Un-operated control group:

Inclusion Criteria:

  • Written informed consent

Exclusion Criteria:

  • Prior RYGB, SG or complicated upper gastrointestinal surgery
  • Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
  • Pregnancy and/or breastfeeding
  • Inadequately treated thyroid disease
  • Serious heart or respiratory illness
  • Haemoglobin < 6,5 mM.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Gastric sleeve operated subjects
12 patients who have undergone gastric sleeve operation >12 month prior to inclution.
Diagnostic test: Mixed meal test with double tracer technique
Control Subjects
12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age
Diagnostic test: Mixed meal test with double tracer technique
Gastric bypass operated subjects
12 patients, who have undergone Roux-en-Y gastric bypass >12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age.
Diagnostic test: Mixed meal test with double tracer technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glucose absorption
Time Frame: 0 - 360 minutes
Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON
0 - 360 minutes
Protein absorption
Time Frame: 0 - 360 minutes
Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON
0 - 360 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glucose absorption
Time Frame: 0 - 360 minutes
Between group difference in peak Ra of oral glucose comparing SG vs. RYGB
0 - 360 minutes
Protein absorption
Time Frame: 0 - 360 minutes
Between groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB
0 - 360 minutes
Glucose kinetics
Time Frame: 0 - 360 minutes
Between groups differences in AUC Ra of oral glucose tracer
0 - 360 minutes
Protein kinetics
Time Frame: 0 - 360 minutes
Between groups differences in AUC Ra of oral aminoacid tracer
0 - 360 minutes
Insulin secretion
Time Frame: 0 - 240 minutes
Between groups differences in iAUC of serum insulin and C-peptide
0 - 240 minutes
Glucagon-like Peptide 1 (GLP-1) secretion
Time Frame: 0 - 240 minutes
Between groups differences in iAUC of plasma concentration of GLP-1
0 - 240 minutes
Glucose-dependent Insulinotropic Peptide (GIP)
Time Frame: 0 - 240 minutes
Between groups differences in iAUC of plasma concentration of GIP
0 - 240 minutes
Ghrelin secretion
Time Frame: 0 - 240 minutes
Between groups differences in iAUC of plasma concentration of ghrelin
0 - 240 minutes
Glucagon secretion
Time Frame: 0-240 minutes
Between groups differences in iAUC of plasma cncentration of glucagon
0-240 minutes
Peptide YY
Time Frame: 0-240 minutes
Between groups differences in iAUC of plasma concentration of PYY
0-240 minutes
Endogenous glucose production
Time Frame: -120 - 360 minutes
Calculated via double tracer tecnique both in the fasting and post prandial state.
-120 - 360 minutes
Lipolysis
Time Frame: -120 - 360
Between groups differences in Rate of Disappearance of glycerol tracer.
-120 - 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hvidovre University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-SGRYGB-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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