search
Back to results

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

Primary Purpose

Severe Obesity

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Colesevelam
Chenodeoxycholic Acid
Water
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Chenodeoxycholic Acid

Colesevelam

Colesevelam x 2

Arm Description

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt

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.

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.

Outcomes

Primary Outcome Measures

GLP-1 secretion (evaluated by iAUC)

Secondary Outcome Measures

Glucose levels
Insulin secretion
PYY secretion
Bile acids/FGF19 concentrations
Appetite measurements (VAS-score)
PCM levels
C-peptide secretion
Glucagon secretion
GIP secretion
CCK secretion
Ghrelin
Total bile acid secretion

Full Information

First Posted
July 1, 2016
Last Updated
November 25, 2020
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT02876484
Brief Title
Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Official Title
Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water
Arm Title
Chenodeoxycholic Acid
Arm Type
Experimental
Arm Description
Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt
Arm Title
Colesevelam
Arm Type
Experimental
Arm Description
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.
Arm Title
Colesevelam x 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Colesevelam
Intervention Type
Drug
Intervention Name(s)
Chenodeoxycholic Acid
Intervention Type
Other
Intervention Name(s)
Water
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Glucose levels
Time Frame
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Insulin secretion
Time Frame
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
PYY secretion
Time Frame
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Bile acids/FGF19 concentrations
Time Frame
-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Appetite measurements (VAS-score)
Time Frame
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
PCM levels
Time Frame
Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Title
C-peptide secretion
Time Frame
Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Title
Glucagon secretion
Time Frame
Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Title
GIP secretion
Time Frame
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
CCK secretion
Time Frame
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Ghrelin
Time Frame
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Total bile acid secretion
Time Frame
0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs