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

June 29, 2016 updated by: Maria Saur Svane, Hvidovre University Hospital

Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, DK-2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
C-peptide secretion (evaluated by iAUC)
Time Frame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
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
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
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
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
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
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
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
TSH/T3/T4
Time Frame: 0, 60, 120, 180
0, 60, 120, 180
Appetite measurements (VAS-score)
Time Frame: Baseline, 30, 60, 120, 180
Baseline, 30, 60, 120, 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SN-GALDE-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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