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Glucose Absorption and Gut Hormone Secretion After Gastric Bypass

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ClinicalTrials.gov Identifier: NCT03426956
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Christoffer Martinussen, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Overweight Dietary Supplement: Glucose Dietary Supplement: Glucose + Canagliflozin Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 10 gastric bypass patients
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass
Estimated Study Start Date : February 8, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Difference in glucose responses between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]
  2. Difference in insulin responses between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]
  3. Difference in C-peptide responses between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]
  4. Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]
  5. Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days. [ Time Frame: 0-240 min following carbohydrate ingestion ]
  6. Difference in glucagon responses (evaluated by iAUC) between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]
  7. Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days. [ Time Frame: 0-240 min following carbohydrate ingestion ]
  8. Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]
  9. Difference in bile acid responses (evaluated by iAUC) between the two test days. [ Time Frame: 0-240 min following glucose ingestion ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426956


Contacts
Contact: Sten Madsbad, Professor +4538623032 sten.madsbad@regionh.dk

Locations
Denmark
Dept. of Endocrinology Recruiting
Hvidovre, Denmark, 2650
Contact: Christoffer Martinussen, MD    +4538623032    christoffer.martinussen@regionh.dk   
Principal Investigator: Christoffer Martinussen, MD         
Sponsors and Collaborators
Hvidovre University Hospital

Responsible Party: Christoffer Martinussen, Principal investigator, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03426956     History of Changes
Other Study ID Numbers: CM-CANA-18
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christoffer Martinussen, Hvidovre University Hospital:
Glucagon-like Peptide-1
Glucose
Gastric bypass
Bariatric surgery
Obesity
Diabetes

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Hormones
Canagliflozin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents