EcholocationPhase 1NCT01674946
Effect of Bile Acids on the Secretion of Satiation Peptides in Humans
A Phase 1 study testing saline, bile acid (CDCA, chenodeoxycholic acid) and oleanolic acid in people with Echolocation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Echolocation
- What is being tested?
- saline, bile acid (CDCA, chenodeoxycholic acid) and oleanolic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- BMI of 19.0-24.5
- Age 18-40
- Stable body weight for at least 3 months
Who cannot join
- Smoking
- Substance abuse
- Regular intake of medication
- Medical of psychiatric illness
- Gastrointestinal disorders or food allergies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Phase 1 Research Unit
Basel, 4031
About this study
Official title: Effect of Intraduodenal Perfusion of Bile Acids on the Secretion of Gastrointestinal Satiation Peptides in Healthy Male Volunteers
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.
Read the detailed description
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
- Echolocation
- Being tested
- saline, bile acid (CDCA, chenodeoxycholic acid), oleanolic acid, oleic acid
- Keywords
- GI-physiology, CDCA, bile acids, TGR5, satiation peptides
- Medical subject headings
- Echolocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineOther
intraduodenal perfusion
bile acid (CDCA, chenodeoxycholic acid)Other
Also called primary bile acid
intraduodenal perfusion
oleanolic acidOther
Also called triterpenoid compound of plant origin
intraduodenal perfusion
oleic acidDietary supplement
Also called fatty acid
intraduodenal perfusion
| Study group | Role | What they receive |
|---|---|---|
| ID saline | Placebo comparator | ID saline by feeding tube Receives: Other: saline |
| ID saline + CDCA (5 mmol/L) | Active comparator | CDCA = chenodeoxycholic acid (primary bile acid) Receives: Other: saline; Other: bile acid (CDCA, chenodeoxycholic acid) |
| ID + CDCA (15 mmol/L) | Active comparator | CDCA = chenodeoxycholic acid (primary bile acid) Receives: Other: saline; Other: bile acid (CDCA, chenodeoxycholic acid) |
| ID saline + oleanolic acid (1 mmol/L) | Active comparator | Not described Receives: Other: saline; Other: oleanolic acid |
| ID saline + CDCA (5 mmol/L) + oleic acid | Active comparator | Not described Receives: Other: saline; Other: bile acid (CDCA, chenodeoxycholic acid); Dietary Supplement: oleic acid |
| ID saline + oleic acid (20 mmol/L) | Placebo comparator | Not described Receives: Other: saline; Dietary Supplement: oleic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal satiation peptide secretion
Assessment of plasma GLP-1, PYY and CCK release to BA and OA stimulation
Measured: 3 hours blood sampling
Secondary outcomes (3)
Serum bile acids
Assessment of serum bile acids levels to BA and OA stimulation
Measured: 3 hours blood sampling
Appetite perceptions during 3 hours using visual analogue scales
Assessment of the following appetite perceptions markers: feelings of hunger, feelings of prospective food consumption, feelings of fullness and feelings of satiety using validated visual analogue scales
Measured: 3 hours
Glucose and insulin secretion
Assessment of plasma glucose and insulin levels to BA and OA stimulation
Measured: 3 hours blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EcholocationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, University Hospital Basel, Phase 1 Research Unit, Basel Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674946
- Sponsor's protocol ID
- EKBB 140/11
- Status last verified
- Aug 2012
- First submitted
- 24 Aug 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraduodenal Perfusion of Bile Acids on the Secretion of Gastrointestinal Satiation Peptides in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01674946
- Acronym / sponsor ID
- EKBB 140/11
- Conditions
- Echolocation
- Keywords
- GI-physiology, CDCA, bile acids, TGR5, satiation peptides
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ID saline | Placebo comparator | Other: salineID saline by feeding tube |
| ID saline + CDCA (5 mmol/L) | Active comparator | Other: saline, Other: bile acid (CDCA, chenodeoxycholic acid)CDCA = chenodeoxycholic acid (primary bile acid) |
| ID + CDCA (15 mmol/L) | Active comparator | Other: saline, Other: bile acid (CDCA, chenodeoxycholic acid)CDCA = chenodeoxycholic acid (primary bile acid) |
| ID saline + oleanolic acid (1 mmol/L) | Active comparator | Other: saline, Other: oleanolic acid |
| ID saline + CDCA (5 mmol/L) + oleic acid | Active comparator | Other: saline, Other: bile acid (CDCA, chenodeoxycholic acid), Dietary Supplement: oleic acid |
| ID saline + oleic acid (20 mmol/L) | Placebo comparator | Other: saline, Dietary Supplement: oleic acid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- BMI of 19.0-24.5
- Age 18-40
- Stable body weight for at least 3 months
Key exclusion criteria (5 listed)
- Smoking
- Substance abuse
- Regular intake of medication
- Medical of psychiatric illness
- Gastrointestinal disorders or food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salineintraduodenal perfusion | Other | ID + CDCA (15 mmol/L), ID saline, ID saline + CDCA (5 mmol/L), ID saline + CDCA (5 mmol/L) + oleic acid, ID saline + oleanolic acid (1 mmol/L), ID saline + oleic acid (20 mmol/L) |
| bile acid (CDCA, chenodeoxycholic acid)Also: primary bile acidintraduodenal perfusion | Other | ID + CDCA (15 mmol/L), ID saline + CDCA (5 mmol/L), ID saline + CDCA (5 mmol/L) + oleic acid |
| oleanolic acidAlso: triterpenoid compound of plant originintraduodenal perfusion | Other | ID saline + oleanolic acid (1 mmol/L) |
| oleic acidAlso: fatty acidintraduodenal perfusion | Dietary supplement | ID saline + CDCA (5 mmol/L) + oleic acid, ID saline + oleic acid (20 mmol/L) |
Primary outcome
Gastrointestinal satiation peptide secretion
Time frame: 3 hours blood sampling
Assessment of plasma GLP-1, PYY and CCK release to BA and OA stimulation
3 secondary outcomes
Serum bile acids
Time frame: 3 hours blood sampling
Appetite perceptions during 3 hours using visual analogue scales
Time frame: 3 hours
Glucose and insulin secretion
Time frame: 3 hours blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, MD principal investigator
University Hospital Basel, Phase 1 Research Unit, Basel Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing saline, bile acid (CDCA, chenodeoxycholic acid) and oleanolic acid in people with Echolocation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal satiation peptide secretion (time frame: 3 hours blood sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.