Glucose Absorption and Gut Hormone Secretion After Gastric Bypass

February 8, 2018 updated by: Christoffer Martinussen, Hvidovre University Hospital

Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass

To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Glucose is a potent stimulus for GLP-1 secretion after gastric bypass surgery and the SGLT-1 transporter appears to be crucial for this response. The study will investigate the effects of SGLT-1/SGLT-2 inhibition (by canagliflozin) on secretion of GLP-1 and other gut hormones after gastric bypass surgery.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

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
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Dept. of Endocrinology

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

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

•Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria:

  • Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glucose
Dietary supplement: Glucose
Ingestion of glucose (50 g) dissolved in 200 ml water.
EXPERIMENTAL: Glucose + Canagliflozin
Dietary supplement: Glucose + Canagliflozin
Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in GLP-1 secretion (evaluated by iAUC).
Time Frame: 0-240 min following glucose ingestion
Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days.
0-240 min following glucose ingestion

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in glucose responses between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion
Difference in insulin responses between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion
Difference in C-peptide responses between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion
Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion
Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.
Time Frame: 0-240 min following carbohydrate ingestion
0-240 min following carbohydrate ingestion
Difference in glucagon responses (evaluated by iAUC) between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion
Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.
Time Frame: 0-240 min following carbohydrate ingestion
0-240 min following carbohydrate ingestion
Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion
Difference in bile acid responses (evaluated by iAUC) between the two test days.
Time Frame: 0-240 min following glucose ingestion
0-240 min following glucose ingestion

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

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 (ANTICIPATED)

February 8, 2018

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (ACTUAL)

February 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM-CANA-18

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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