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Effect of Bile Acids on the Secretion of Satiation Peptides in Humans

NCT ID: NCT01674946

Last Updated: 2012-08-29

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

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is do determine the functional significance of the G protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.

Detailed Description

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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.

Conditions

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Echolocation

Keywords

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GI-physiology CDCA bile acids TGR5 satiation peptides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ID saline

ID saline by feeding tube

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

intraduodenal perfusion

ID saline + CDCA (5 mmol/L)

CDCA = chenodeoxycholic acid (primary bile acid)

Group Type ACTIVE_COMPARATOR

saline

Intervention Type OTHER

intraduodenal perfusion

bile acid (CDCA, chenodeoxycholic acid)

Intervention Type OTHER

intraduodenal perfusion

ID + CDCA (15 mmol/L)

CDCA = chenodeoxycholic acid (primary bile acid)

Group Type ACTIVE_COMPARATOR

saline

Intervention Type OTHER

intraduodenal perfusion

bile acid (CDCA, chenodeoxycholic acid)

Intervention Type OTHER

intraduodenal perfusion

ID saline + oleanolic acid (1 mmol/L)

Group Type ACTIVE_COMPARATOR

saline

Intervention Type OTHER

intraduodenal perfusion

oleanolic acid

Intervention Type OTHER

intraduodenal perfusion

ID saline + CDCA (5 mmol/L) + oleic acid

Group Type ACTIVE_COMPARATOR

saline

Intervention Type OTHER

intraduodenal perfusion

bile acid (CDCA, chenodeoxycholic acid)

Intervention Type OTHER

intraduodenal perfusion

oleic acid

Intervention Type DIETARY_SUPPLEMENT

intraduodenal perfusion

ID saline + oleic acid (20 mmol/L)

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

intraduodenal perfusion

oleic acid

Intervention Type DIETARY_SUPPLEMENT

intraduodenal perfusion

Interventions

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saline

intraduodenal perfusion

Intervention Type OTHER

bile acid (CDCA, chenodeoxycholic acid)

intraduodenal perfusion

Intervention Type OTHER

oleanolic acid

intraduodenal perfusion

Intervention Type OTHER

oleic acid

intraduodenal perfusion

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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primary bile acid triterpenoid compound of plant origin fatty acid

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* BMI of 19.0-24.5
* Age 18-40
* Stable body weight for at least 3 months

Exclusion Criteria

* Smoking
* Substance abuse
* Regular intake of medication
* Medical of psychiatric illness
* Gastrointestinal disorders or food allergies
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Phase 1 Research Unit, Basel Switzerland

Locations

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University Hospital Basel, Phase 1 Research Unit

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKBB 140/11

Identifier Type: -

Identifier Source: org_study_id