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

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ClinicalTrials.gov Identifier: NCT02876484
Recruitment Status : Unknown
Verified August 2016 by Maria Saur Svane, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : August 23, 2016
Last Update Posted : August 23, 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 effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Placebo

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM.

25 ml water

Other: Water
Experimental: Chenodeoxycholic Acid

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM.

Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt.

Drug: Chenodeoxycholic Acid
Experimental: Colesevelam

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM.

Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt

Drug: Colesevelam



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

Secondary Outcome Measures :
  1. Glucose levels [ Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  2. Insulin secretion [ Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  3. PYY secretion [ Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  4. Bile acids/FGF19 concentrations [ Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  5. Appetite measurements (VAS-score) [ Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  6. PCM levels [ Time Frame: Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes ]
  7. C-peptide secretion [ Time Frame: Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes ]
  8. Glucagon secretion [ Time Frame: Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes ]
  9. GIP secretion [ Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  10. CCK secretion [ Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  11. Ghrelin [ Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]
  12. Total bile acid secretion [ Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes ]


Information from the National Library of Medicine

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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 plasma 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): NCT02876484


Contacts
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Contact: Isabella Jonsson +4538626374 Isabella.jonsson.01@regionh.dk
Contact: Sten Madsbad, Prof Sten.Madsbad@regionh.dk

Locations
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Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, DK-2650
Contact: Maria S Svane, MD    +45 38626357    Maria.Saur.Svane@regionh.dk   
Contact: Sten Madsbad, MD, DMSc         
Sub-Investigator: Isabella Jonsson         
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen

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Responsible Party: Maria Saur Svane, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02876484    
Other Study ID Numbers: IJ-G2-16
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 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
Chenodeoxycholic Acid
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Gastrointestinal Agents
Cathartics