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

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

Sponsors

Lead Sponsor: Hvidovre University Hospital

Collaborator: University of Copenhagen

Source Hvidovre University Hospital
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.

Overall Status Completed
Start Date November 2014
Primary Completion Date April 2015
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
GLP-1 secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Secondary Outcome
Measure Time Frame
C-peptide secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
PYY secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Glucagon secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
GIP secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
CCK secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Gherlin secretion (evaluated by iAUC) Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Changes in bile acids/FGF-19 Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
TSH/T3/T4 0, 60, 120, 180
Appetite measurements (VAS-score) Baseline, 30, 60, 120, 180
Enrollment 11
Condition
Intervention

Intervention Type: Other

Intervention Name: Water

Arm Group Label: Placebo

Intervention Type: Drug

Intervention Name: Ursodeoxycholic Acid

Arm Group Label: Ursodeoxycholic acid

Intervention Type: Drug

Intervention Name: Chenodeoxycholic Acid

Arm Group Label: Chenodeoxycholic acid

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).

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Hvidovre University Hospital
Location Countries

Denmark

Verification Date

June 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hvidovre University Hospital

Investigator Full Name: Maria Saur Svane

Investigator Title: MD

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Placebo

Type: Experimental

Description: 150mL water

Label: Ursodeoxycholic acid

Type: Experimental

Description: Ursodeoxycholic acid (750mg) dissolved in 150mL water

Label: Chenodeoxycholic acid

Type: Experimental

Description: Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Study Design Info

Allocation: Non-Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov