NCT03426956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

February 2, 2018

Last Update Submit

February 8, 2018

Conditions

Overweight

Keywords

Glucagon-like Peptide-1GlucoseGastric bypassBariatric surgeryObesityDiabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Difference in glucose responses between the two test days.

    0-240 min following glucose ingestion

  • Difference in insulin responses between the two test days.

    0-240 min following glucose ingestion

  • Difference in C-peptide responses between the two test days.

    0-240 min following glucose ingestion

  • Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.

    0-240 min following glucose ingestion

  • Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.

    0-240 min following carbohydrate ingestion

  • +4 more secondary outcomes

Study Arms (2)

Glucose

EXPERIMENTAL
Dietary Supplement: Glucose

Glucose + Canagliflozin

EXPERIMENTAL
Dietary Supplement: Glucose + Canagliflozin

Interventions

GlucoseDIETARY_SUPPLEMENT

Ingestion of glucose (50 g) dissolved in 200 ml water.

Glucose
Glucose + CanagliflozinDIETARY_SUPPLEMENT

Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.

Glucose + Canagliflozin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Endocrinology

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus

Interventions

GlucoseCanagliflozin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosides

Central Study Contacts

Sten Madsbad, Professor

CONTACT

+4538623032sten.madsbad@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 10 gastric bypass patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Medical Doctor

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 8, 2018

Study Start

February 8, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

DK(1)