Normal Non-fluencyNCT01366768
Gut Hormones After Oral Versus Intravenous Amino Acids
A study testing Oral amino acid mixture and Intravenous amino acid administration in people with Normal Non-fluency, run by Lund University at 1 site in Sweden.
Trial summary
The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Non-fluency
- What is being tested?
- Oral amino acid mixture and Intravenous amino acid administration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to Sep 2012
- Phase
- Interventional
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
Who cannot join
- Diabetes
- Liver disease
- Kidney disease
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Sciences Lund, Lund University
Lund, 221 84
About this study
Official title: Release of Gut Hormones After Oral Versus Intravenous Amino Acids
The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.
Read the detailed description
Amino acid mixture is given orally or intravenously to match total concentrations of amino acids in healthy subjects. Samples are taken regularly for 300 min after administrations. Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and glucagon.
- Conditions
- Normal Non-fluency
- Being tested
- Oral amino acid mixture, Intravenous amino acid administration
- Keywords
- Gut hormones, Insulin secretion, Normal physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral amino acid mixtureOther
Also called Amino acid mixture
Amino acid mixture 2,93 ml/kg
Intravenous amino acid administrationOther
Also called Amino acid mixture
Amino acid mixture 2,93 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Oral amino acid mixture | Experimental | Oral administration of amino acid mixture in healthy volunteers Receives: Other: Oral amino acid mixture |
| Intravenous amino acid administration | Experimental | Intravenous infusion of amino acid mixture in healthy volunteers Receives: Other: Intravenous amino acid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut hormone secretion
Measured: 300 min
Secondary outcomes (1)
Insulin secretion
Measured: 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Non-fluencyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ahren, Lund University
- Investigators
- Bo Ahrén, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366768
- Sponsor's protocol ID
- 003
- Status last verified
- Oct 2012
- First submitted
- 31 May 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Release of Gut Hormones After Oral Versus Intravenous Amino Acids
- ClinicalTrials.gov ID
- NCT01366768
- Acronym / sponsor ID
- 003
- Conditions
- Normal Non-fluency
- Keywords
- Gut hormones, Insulin secretion, Normal physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jun 2011 (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 study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.
Detailed description
Amino acid mixture is given orally or intravenously to match total concentrations of amino acids in healthy subjects. Samples are taken regularly for 300 min after administrations. Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and glucagon.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral amino acid mixture | Experimental | Other: Oral amino acid mixtureOral administration of amino acid mixture in healthy volunteers |
| Intravenous amino acid administration | Experimental | Other: Intravenous amino acid administrationIntravenous infusion of amino acid mixture in healthy volunteers |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (4 listed)
- Diabetes
- Liver disease
- Kidney disease
- Thyroid disease
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 |
|---|---|---|
| Oral amino acid mixtureAlso: Amino acid mixtureAmino acid mixture 2,93 ml/kg | Other | Oral amino acid mixture |
| Intravenous amino acid administrationAlso: Amino acid mixtureAmino acid mixture 2,93 ml/kg | Other | Intravenous amino acid administration |
Primary outcome
Gut hormone secretion
Time frame: 300 min
1 secondary outcome
Insulin secretion
Time frame: 300 min
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 10 Oct 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.
Bo Ahrén, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral amino acid mixture and Intravenous amino acid administration in people with Normal Non-fluency, run by Lund University at 1 site in Sweden.
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 1 inclusion and 4 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 10 Oct 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 Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Gut hormone secretion (time frame: 300 min). 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 10 Oct 2012.