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Effects of Bile Acids 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: NCT02340247
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : June 30, 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 acids on GLP-1 secretion after Roux-en-Y gastric bypass.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Study Start Date : November 2014
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Placebo
150mL water
Other: Water
Experimental: Ursodeoxycholic acid
Ursodeoxycholic acid (750mg) dissolved in 150mL water
Drug: Ursodeoxycholic Acid
Experimental: Chenodeoxycholic acid
Chenodeoxycholic acid (1250mg) dissolved in 150mL water
Drug: Chenodeoxycholic Acid



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

Secondary Outcome Measures :
  1. C-peptide secretion (evaluated by iAUC) [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  2. PYY secretion (evaluated by iAUC) [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  3. Glucagon secretion (evaluated by iAUC) [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  4. GIP secretion (evaluated by iAUC) [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  5. CCK secretion (evaluated by iAUC) [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  6. Gherlin secretion (evaluated by iAUC) [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  7. Changes in bile acids/FGF-19 [ Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 ]
  8. TSH/T3/T4 [ Time Frame: 0, 60, 120, 180 ]
  9. Appetite measurements (VAS-score) [ Time Frame: Baseline, 30, 60, 120, 180 ]


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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 < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.

Exclusion Criteria:

  • Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
  • Dysregulated hypothyroidism, 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).

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): NCT02340247


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
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: NCT02340247    
Other Study ID Numbers: SN-GALDE-14
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Ursodeoxycholic Acid
Chenodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Cathartics