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Effects of Bile Acids 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
Water
Ursodeoxycholic Acid
Chenodeoxycholic Acid
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science 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 < 7.0mM, 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).

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Placebo

Ursodeoxycholic acid

Chenodeoxycholic acid

Arm Description

150mL water

Ursodeoxycholic acid (750mg) dissolved in 150mL water

Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Outcomes

Primary Outcome Measures

GLP-1 secretion (evaluated by iAUC)

Secondary Outcome Measures

C-peptide secretion (evaluated by iAUC)
PYY secretion (evaluated by iAUC)
Glucagon secretion (evaluated by iAUC)
GIP secretion (evaluated by iAUC)
CCK secretion (evaluated by iAUC)
Gherlin secretion (evaluated by iAUC)
Changes in bile acids/FGF-19
TSH/T3/T4
Appetite measurements (VAS-score)

Full Information

First Posted
January 13, 2015
Last Updated
June 29, 2016
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02340247
Brief Title
Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Official Title
Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)

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 acids on GLP-1 secretion 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
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
150mL water
Arm Title
Ursodeoxycholic acid
Arm Type
Experimental
Arm Description
Ursodeoxycholic acid (750mg) dissolved in 150mL water
Arm Title
Chenodeoxycholic acid
Arm Type
Experimental
Arm Description
Chenodeoxycholic acid (1250mg) dissolved in 150mL water
Intervention Type
Other
Intervention Name(s)
Water
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Intervention Type
Drug
Intervention Name(s)
Chenodeoxycholic Acid
Primary Outcome Measure Information:
Title
GLP-1 secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Secondary Outcome Measure Information:
Title
C-peptide secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
PYY secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
Glucagon secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
GIP secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
CCK secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
Gherlin secretion (evaluated by iAUC)
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
Changes in bile acids/FGF-19
Time Frame
Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Title
TSH/T3/T4
Time Frame
0, 60, 120, 180
Title
Appetite measurements (VAS-score)
Time Frame
Baseline, 30, 60, 120, 180

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 < 7.0mM, 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).
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark

12. IPD Sharing Statement

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

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