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

NCT ID: NCT02340247

Last Updated: 2016-06-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

150mL water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Ursodeoxycholic acid

Ursodeoxycholic acid (750mg) dissolved in 150mL water

Group Type EXPERIMENTAL

Ursodeoxycholic Acid

Intervention Type DRUG

Chenodeoxycholic acid

Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Group Type EXPERIMENTAL

Chenodeoxycholic Acid

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Water

Intervention Type OTHER

Ursodeoxycholic Acid

Intervention Type DRUG

Chenodeoxycholic Acid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria Saur Svane

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SN-GALDE-14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fat Metabolites and Gut Hormones
NCT03223389 UNKNOWN NA