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

NCT ID: NCT02876484

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-11-30

Brief Summary

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The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, 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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Placebo

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM.

25 ml water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Chenodeoxycholic Acid

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt

Group Type EXPERIMENTAL

Chenodeoxycholic Acid

Intervention Type DRUG

Colesevelam

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Group Type EXPERIMENTAL

Colesevelam

Intervention Type DRUG

Colesevelam x 2

plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Group Type EXPERIMENTAL

Colesevelam

Intervention Type DRUG

Interventions

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Colesevelam

Intervention Type DRUG

Chenodeoxycholic Acid

Intervention Type DRUG

Water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Uncomplicated RYGB performed minimum 3 months prior to the study.
* Fasting plasma 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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IJ-G2-16

Identifier Type: -

Identifier Source: org_study_id