Back to resultsEffect of Bile Acids and Bile Acid Sequstrants 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
Chenodeoxycholic Acid
Colesevelam
Sponsored by
About this trial
This is an interventional treatment trial for Severe Obesity
Eligibility Criteria
Inclusion Criteria:
- Uncomplicated RYGB performed minimum 3 months prior to the study.
- Fasting 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 Type
Experimental
Experimental
Arm Label
Chenodeoxycholic Acid
Chenodeoxycholic Acid and Colesevelam
Arm Description
Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.
Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.
Outcomes
Primary Outcome Measures
GLP-1 secretion (evaluated by iAUC)
Secondary Outcome Measures
Glucose levels
PYY secretion
Glucagon secretion
GIP secretion
Insulin secretion
C-peptide secretion
CCK secretion
Total ghrelin
Total bile acid secretion
Bile acids fractions / FGF-19 concentrations
Appetite measurements (VAS-score)
Full Information
NCT ID
NCT02952963
First Posted
November 1, 2016
Last Updated
November 25, 2020
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02952963
Brief Title
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Official Title
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 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 efffects of bile acid and bile acids sequestrants on GLP-1 secretion, 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
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chenodeoxycholic Acid
Arm Type
Experimental
Arm Description
Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.
Arm Title
Chenodeoxycholic Acid and Colesevelam
Arm Type
Experimental
Arm Description
Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.
Intervention Type
Drug
Intervention Name(s)
Chenodeoxycholic Acid
Intervention Type
Drug
Intervention Name(s)
Colesevelam
Primary Outcome Measure Information:
Title
GLP-1 secretion (evaluated by iAUC)
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.
Secondary Outcome Measure Information:
Title
Glucose levels
Time Frame
-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
PYY secretion
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Glucagon secretion
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
GIP secretion
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Insulin secretion
Time Frame
-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
C-peptide secretion
Time Frame
-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
CCK secretion
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Total ghrelin
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Total bile acid secretion
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Bile acids fractions / FGF-19 concentrations
Time Frame
-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Title
Appetite measurements (VAS-score)
Time Frame
-10, 30, 60, 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 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
State/Province
DK
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
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