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

NCT ID: NCT02952963

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chenodeoxycholic Acid

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

Group Type EXPERIMENTAL

Chenodeoxycholic Acid

Intervention Type DRUG

Chenodeoxycholic Acid and Colesevelam

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

Group Type EXPERIMENTAL

Chenodeoxycholic Acid

Intervention Type DRUG

Colesevelam

Intervention Type DRUG

Interventions

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Chenodeoxycholic Acid

Intervention Type DRUG

Colesevelam

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maria Saur Svane

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, DK, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IJ-GALDE3-16

Identifier Type: -

Identifier Source: org_study_id