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

Overview

The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.

Full Title of Study: “Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

Interventions

  • Other: Water
  • Drug: Ursodeoxycholic Acid
  • Drug: Chenodeoxycholic Acid

Arms, Groups and Cohorts

  • Experimental: Placebo
    • 150mL water
  • Experimental: Ursodeoxycholic acid
    • Ursodeoxycholic acid (750mg) dissolved in 150mL water
  • Experimental: Chenodeoxycholic acid
    • Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Clinical Trial Outcome Measures

Primary Measures

  • GLP-1 secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

Secondary Measures

  • C-peptide secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • PYY secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • Glucagon secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • GIP secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • CCK secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • Gherlin secretion (evaluated by iAUC)
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • Changes in bile acids/FGF-19
    • Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
  • TSH/T3/T4
    • Time Frame: 0, 60, 120, 180
  • Appetite measurements (VAS-score)
    • Time Frame: Baseline, 30, 60, 120, 180

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Collaborator
    • University of Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Saur Svane, MD – Hvidovre University Hospital

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