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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02952963

Collaborator

University of Copenhagen (Other)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Obesity	Drug: Chenodeoxycholic Acid Drug: Colesevelam	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chenodeoxycholic Acid Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.	Drug: Chenodeoxycholic Acid
Experimental: Chenodeoxycholic Acid and Colesevelam Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.	Drug: Chenodeoxycholic Acid Drug: Colesevelam

Arm

Intervention/Treatment

Experimental: Chenodeoxycholic Acid

Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.

Drug: Chenodeoxycholic Acid

Experimental: Chenodeoxycholic Acid and Colesevelam

Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.

Drug: Chenodeoxycholic Acid

Drug: Colesevelam

Outcome Measures

Primary Outcome Measures

GLP-1 secretion (evaluated by iAUC) [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.]

Secondary Outcome Measures

Glucose levels [-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
PYY secretion [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
Glucagon secretion [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
GIP secretion [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
Insulin secretion [-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
C-peptide secretion [-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
CCK secretion [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
Total ghrelin [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
Total bile acid secretion [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
Bile acids fractions / FGF-19 concentrations [-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes]
Appetite measurements (VAS-score) [-10, 30, 60, 120, 180 and 240 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Hvidovre	DK	Denmark	2650

Sponsors and Collaborators

Hvidovre University Hospital
University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Saur Svane, MD, Principal Investigator, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT02952963

Other Study ID Numbers:

IJ-GALDE3-16

First Posted:

Nov 2, 2016

Last Update Posted:

Nov 30, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Obesity, Morbid

Chenodeoxycholic Acid

Colesevelam Hydrochloride

Study Results

No Results Posted as of Nov 30, 2020