Back to resultsGlucose Absorption and Gut Hormone Secretion After Gastric Bypass
Primary Purpose
Overweight
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Glucose
Glucose + Canagliflozin
Sponsored by
About this trial
This is an interventional basic science trial for Overweight focused on measuring Glucagon-like Peptide-1, Glucose, Gastric bypass, Bariatric surgery, Obesity, Diabetes
Eligibility Criteria
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
Sites / Locations
- Dept. of EndocrinologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glucose
Glucose + Canagliflozin
Arm Description
Outcomes
Primary Outcome Measures
Difference in GLP-1 secretion (evaluated by iAUC).
Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days.
Secondary Outcome Measures
Difference in glucose responses between the two test days.
Difference in insulin responses between the two test days.
Difference in C-peptide responses between the two test days.
Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.
Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.
Difference in glucagon responses (evaluated by iAUC) between the two test days.
Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.
Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.
Difference in bile acid responses (evaluated by iAUC) between the two test days.
Full Information
NCT ID
NCT03426956
First Posted
February 2, 2018
Last Updated
February 8, 2018
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03426956
Brief Title
Glucose Absorption and Gut Hormone Secretion After Gastric Bypass
Official Title
Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2018 (Anticipated)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Glucagon-like Peptide-1, Glucose, Gastric bypass, Bariatric surgery, Obesity, Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
10 gastric bypass patients
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucose
Arm Type
Experimental
Arm Title
Glucose + Canagliflozin
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Ingestion of glucose (50 g) dissolved in 200 ml water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose + Canagliflozin
Intervention Description
Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.
Primary Outcome Measure Information:
Title
Difference in GLP-1 secretion (evaluated by iAUC).
Description
Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following glucose ingestion
Secondary Outcome Measure Information:
Title
Difference in glucose responses between the two test days.
Time Frame
0-240 min following glucose ingestion
Title
Difference in insulin responses between the two test days.
Time Frame
0-240 min following glucose ingestion
Title
Difference in C-peptide responses between the two test days.
Time Frame
0-240 min following glucose ingestion
Title
Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following glucose ingestion
Title
Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following carbohydrate ingestion
Title
Difference in glucagon responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following glucose ingestion
Title
Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following carbohydrate ingestion
Title
Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following glucose ingestion
Title
Difference in bile acid responses (evaluated by iAUC) between the two test days.
Time Frame
0-240 min following glucose ingestion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sten Madsbad, Professor
Phone
+4538623032
Email
sten.madsbad@regionh.dk
Facility Information:
Facility Name
Dept. of Endocrinology
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoffer Martinussen, MD
Phone
+4538623032
Email
christoffer.martinussen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Christoffer Martinussen, MD
12. IPD Sharing Statement
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Glucose Absorption and Gut Hormone Secretion After Gastric Bypass
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