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NCT03426956 Clinical Trial

Glucose Absorption and Gut Hormone Secretion After Gastric Bypass

Overweight Clinical Trial

Official title:
Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03426956
Other study ID # CM-CANA-18
Secondary ID
Status Recruiting
Phase N/A
First received February 2, 2018
Last updated February 8, 2018
Start date February 8, 2018
Est. completion date May 1, 2019

Study information
Verified date February 2018
Source Hvidovre University Hospital
Contact Sten Madsbad, Professor
Phone +4538623032
Email sten.madsbad@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Glucose
Ingestion of glucose (50 g) dissolved in 200 ml water.
• Glucose + Canagliflozin
Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.

Locations
Country Name City State
Denmark Dept. of Endocrinology Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in GLP-1 secretion (evaluated by iAUC). Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days. 0-240 min following glucose ingestion
Secondary Difference in glucose responses between the two test days. 0-240 min following glucose ingestion
Secondary Difference in insulin responses between the two test days. 0-240 min following glucose ingestion
Secondary Difference in C-peptide responses between the two test days. 0-240 min following glucose ingestion
Secondary Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days. 0-240 min following glucose ingestion
Secondary Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days. 0-240 min following carbohydrate ingestion
Secondary Difference in glucagon responses (evaluated by iAUC) between the two test days. 0-240 min following glucose ingestion
Secondary Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days. 0-240 min following carbohydrate ingestion
Secondary Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days. 0-240 min following glucose ingestion
Secondary Difference in bile acid responses (evaluated by iAUC) between the two test days. 0-240 min following glucose ingestion
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