OverweightNCT03426956
Glucose Absorption and Gut Hormone Secretion After Gastric Bypass
A study testing Glucose and Glucose + Canagliflozin in people with Overweight, run by Hvidovre University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight
- What is being tested?
- Glucose and Glucose + Canagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Uncomplicated gastric bypass surgery performed minimum 12 months prior to study
Who cannot join
- Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
- Pregnancy or breastfeeding
- Haemoglobin levels below 6,5 mM
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of Endocrinology
Hvidovre, 2650
Christoffer Martinussen, MD, +4538623032, christoffer.martinussen@regionh.dk
Christoffer Martinussen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Glucose, Glucose + Canagliflozin
- Keywords
- Glucagon-like Peptide-1, Glucose, Gastric bypass, Bariatric surgery, Obesity, Diabetes
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDietary supplement
Ingestion of glucose (50 g) dissolved in 200 ml water.
Glucose + CanagliflozinDietary supplement
Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Experimental | Not described Receives: Dietary Supplement: Glucose |
| Glucose + Canagliflozin | Experimental | Not described Receives: Dietary Supplement: Glucose + Canagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in GLP-1 secretion (evaluated by iAUC).
Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following glucose ingestion
Secondary outcomes (9)
Difference in glucose responses between the two test days.
Measured: 0-240 min following glucose ingestion
Difference in insulin responses between the two test days.
Measured: 0-240 min following glucose ingestion
Difference in C-peptide responses between the two test days.
Measured: 0-240 min following glucose ingestion
Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following glucose ingestion
Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following carbohydrate ingestion
Difference in glucagon responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following glucose ingestion
Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following carbohydrate ingestion
Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following glucose ingestion
Difference in bile acid responses (evaluated by iAUC) between the two test days.
Measured: 0-240 min following glucose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start8 Feb 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 10 gastric bypass patients
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoffer Martinussen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426956
- Sponsor's protocol ID
- CM-CANA-18
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass
- ClinicalTrials.gov ID
- NCT03426956
- Acronym / sponsor ID
- CM-CANA-18
- Conditions
- Overweight
- Keywords
- Glucagon-like Peptide-1, Glucose, Gastric bypass, Bariatric surgery, Obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 8 Feb 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 10 gastric bypass patients
| Arm | Type | Receives |
|---|---|---|
| Glucose | Experimental | Dietary Supplement: Glucose |
| Glucose + Canagliflozin | Experimental | Dietary Supplement: Glucose + Canagliflozin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Uncomplicated gastric bypass surgery performed minimum 12 months prior to study
Key exclusion criteria (3 listed)
- Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
- Pregnancy or breastfeeding
- Haemoglobin levels below 6,5 mM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoseIngestion of glucose (50 g) dissolved in 200 ml water. | Dietary supplement | Glucose |
| Glucose + CanagliflozinIngestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin. | Dietary supplement | Glucose + Canagliflozin |
Primary outcome
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.
9 secondary outcomes
Difference in glucose responses between the two test days.
Time frame: 0-240 min following glucose ingestion
Difference in insulin responses between the two test days.
Time frame: 0-240 min following glucose ingestion
Difference in C-peptide responses between the two test days.
Time frame: 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
Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.
Time frame: 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
Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.
Time frame: 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
Difference in bile acid responses (evaluated by iAUC) between the two test days.
Time frame: 0-240 min following glucose ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose and Glucose + Canagliflozin in people with Overweight, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sten Madsbad, Professor (+4538623032, sten.madsbad@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in GLP-1 secretion (evaluated by iAUC). (time frame: 0-240 min following glucose ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.