Completed

Effect of Intraduodenal Perfusion of Bile Acids on the Secretion of Gastrointestinal Satiation Peptides in Healthy Male Volunteers

What is being tested

saline

+ saline

+ bile acid (CDCA, chenodeoxycholic acid)

OtherDietary Supplement

Who is being recruted

Animal Communication+1

+ Behavior

+ Behavior, Animal

From 18 to 40 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: September 2011

See protocol details

Summary

Principal SponsorUniversity Hospital, Basel, Switzerland

Last updated: August 29, 2012

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

TGR5 is expressed in GLP-1-secreting cell lines and L cells from mice; gain- and loss-of-function models suggest a physiological role for TGR5 activation on GLP-1 secretion in rodents. TGR5 signaling showed improved postprandial glucose tolerance in obese mice, associated with marked postprandial GLP-1 release and insulin secretion. In contrast, TGR5-/- mice exhibited reduced glucose tolerance. In animals, TGR5 activation has been shown for natural bile acids (BAs) and triterpenoid compounds of plant origin, such as oleanolic acid (OA), suggesting a role for postprandial BAs in modulating nutrient-induced GLP-1 secretion. We therefore hypothesized that intraduodenal (ID) perfusions of TGR5 agonists (BAs and OA) stimulate the secretion of GLP-1 with respective changes in the glucose metabolism of healthy humans.

NCT01674946

Principal SponsorUniversity Hospital, Basel, Switzerland

Last updated: August 29, 2012

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Animal CommunicationBehaviorBehavior, AnimalEcholocation

Criteria

4 inclusion criteria required to participate

Age 18-40

BMI of 19.0-24.5

Healthy subjects

Stable body weight for at least 3 months

5 exclusion criteria prevent from participating

Gastrointestinal disorders or food allergies

Medical of psychiatric illness

Regular intake of medication

Smoking

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

ID saline by feeding tube

Group II

Active Comparator

CDCA = chenodeoxycholic acid (primary bile acid)

Group III

Active Comparator

CDCA = chenodeoxycholic acid (primary bile acid)

Group IV

Active Comparator

Group 5

Active Comparator

Group 6

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital Basel, Phase 1 Research Unit

Basel, SwitzerlandOpen University Hospital Basel, Phase 1 Research Unit in Google Maps

CompletedOne Study Center