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Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952963
Recruitment Status : Unknown
Verified November 2016 by Maria Saur Svane, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Maria Saur Svane, Hvidovre University Hospital

Brief Summary:
The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.

Condition or disease Intervention/treatment Phase
Severe Obesity Drug: Chenodeoxycholic Acid Drug: Colesevelam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Study Start Date : October 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chenodeoxycholic Acid
Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.
Drug: Chenodeoxycholic Acid
Experimental: Chenodeoxycholic Acid and Colesevelam
Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.
Drug: Chenodeoxycholic Acid
Drug: Colesevelam



Primary Outcome Measures :
  1. GLP-1 secretion (evaluated by iAUC) [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake. ]

Secondary Outcome Measures :
  1. Glucose levels [ Time Frame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  2. PYY secretion [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  3. Glucagon secretion [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  4. GIP secretion [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  5. Insulin secretion [ Time Frame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  6. C-peptide secretion [ Time Frame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  7. CCK secretion [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  8. Total ghrelin [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  9. Total bile acid secretion [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  10. Bile acids fractions / FGF-19 concentrations [ Time Frame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  11. Appetite measurements (VAS-score) [ Time Frame: -10, 30, 60, 120, 180 and 240 minutes ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncomplicated RYGB performed minimum 3 months prior to the study.
  • Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB

Exclusion Criteria:

  • Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB
  • Dysregulated thyroid diseases, use of antithyroid treatment.
  • Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
  • Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)
  • Cholecystectomy.

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): NCT02952963


Contacts
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Contact: Isabella Jonsson +4538622124 isabella.jonsson.01@regionh.dk
Contact: Sten Madsbad, Prof. sten.madsbad@regionh.dk

Locations
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Denmark
Hvidovre University Hospital Recruiting
Hvidovre, DK, Denmark, 2650
Contact: Maria S Svane, MD    +4538626357    maria.saur.svane@regionh.dk   
Contact: Sten Madsbad, MD         
Sub-Investigator: Isabella Jonsson, stud.med.         
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen

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Responsible Party: Maria Saur Svane, MD, Principal Investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02952963    
Other Study ID Numbers: IJ-GALDE3-16
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bile Acids and Salts
Chenodeoxycholic Acid
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Gastrointestinal Agents
Cathartics