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

November 25, 2020 updated by: Maria Saur Svane, Hvidovre University Hospital

Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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 < 7,0 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Experimental: Colesevelam x 2
plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose levels
Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Insulin secretion
Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion
Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids/FGF19 concentrations
Time Frame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)
Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PCM levels
Time Frame: Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
C-peptide secretion
Time Frame: Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Glucagon secretion
Time Frame: Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
GIP secretion
Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion
Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Ghrelin
Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion
Time Frame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

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

June 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJ-G2-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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