HealthyPhase 1APELINSNCT02033473
Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
A Phase 1 study testing Apelin in people with Healthy, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue. Recent work by the team of Prof. 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
- Healthy
- What is being tested?
- Apelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Oct 2014
- 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
- Men aged 18 to 40 years.
- BMI between 25 and 30 kg / cm ² (excluding terminals).
- Free of known chronic disease and any medication (any medication within 30 days prior to the inclusion visit).
- Non-pathological ECG.
- Heart rate between 50 and 80 beats per minute rest.
- Complete Blood Count (CBC) with no significant anomaly in terms of the investigator.
Show all 16Show fewer
- Liver function tests without clinically significant abnormalities in terms of the investigator.
- Renal function tests without clinically significant abnormalities in terms of the investigator.
- Serum electrolytes without clinically significant abnormalities in terms of the investigator.
- Fasting plasma glucose less than 1.1 g / l.
- HbA1c within the normal range (4-6%).
- Good peripheral vein (forearm and back of the hand).
- Agreement to participate in the establishment of a serum bank.
- Sedentary or practicing occasional physical activity.
- Ability to sign informed consent.
- Affiliation to a social security scheme.
Who cannot join
- Risk factor, treatment or ECG as recommended by International Conference on Harmonization E14 (ICH E14) "Clinical Evaluation of QT / corrected QT interval (QTc Interval= Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"
- Repeated a QTc interval> 450 ms measurement
- Risk factor: myocardial infarction, hypokalemia, family history of long QT syndrome
- Personal history of cancer.
- Positive HIV serology.
- Hepatitis B serology positive.
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- Positive hepatitis C serology.
- Cognitive impairment or mental illness (at the discretion of the investigator).
- Chronic excessive alcohol consumption (consumption> 30g/jour or 210g/week).
- Person under judicial protection, guardianship.
- Subject with a resting systolic blood pressure greater than 140 mm Hg and diastolic blood pressure greater than 90 mmHg
- Smoking> 10 cig / day and can not be interrupted for 24 hours.
- Subject exclusion period of another protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.
Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.
- Conditions
- Healthy
- Being tested
- Apelin, Placebo
- Keywords
- Apelin, insulin, volunteers
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApelinDrug
An apelin clamp in which an apelin infusion will be administered
PlaceboDrug
A clamp reference during which a placebo solution (saline solution) will be administered
| Study group | Role | What they receive |
|---|---|---|
| Apelin | Experimental | An apelin clamp in which an apelin infusion will be administered prior to reference clamp Receives: Drug: Apelin; Drug: Placebo |
| Placebo | Placebo comparator | A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp Receives: Drug: Apelin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of glucose infusion
Measuring the difference between the rate of glucose infusion measured in the last 30 minutes of a hyperinsulinemic euglycemic clamp in the presence of a continuous infusion (PYR1)-apelin-13 infusion rate of glucose measured in the same conditions in the presence of a continuous infusion of placebo.
Measured: The last 30 minutes of a hyperinsulinemic euglycemic clamp
Secondary outcomes (11)
Calculation of the index of insulin sensitivity (Si)
Measured: During 240 minutes at visits 2 and 3
Changes in the measurement of systolic blood pressure during each clamp
Measured: During 240 minutes at visits 2 and 3
Changes in the measurement of diastolic blood pressure during each clamp
Measured: During 240 minutes at visits 2 and 3
Changes in heart rate measurement during each clamp
Measured: During 240 minutes at visits 2 and 3
Changes in ECG during each clamp
Measured: During 240 minutes at visits 2 and 3
Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4
Measured: During 240 minutes at visits 2 and 3
Determination of plasma insulin at all sampling
Measured: During 240 minutes at visits 2 and 3
Determination of plasma glucagon at all sampling times
Measured: During 240 minutes at visits 2 and 3
Determination of plasma apelin at all sampling times
Measured: During 240 minutes at visits 2 and 3
Determination of plasma leptin at all sampling times
Measured: During 240 minutes at visits 2 and 3
Determination of plasma adiponectin at all sampling times
Measured: During 240 minutes at visits 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre GOURDY, Md, PhD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033473
- Sponsor's protocol ID
- 13 182 03
- Other IDs
- HAO 2013
- Acronym
- APELINS
- Status last verified
- Jul 2019
- First submitted
- 12 Dec 2013
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.
PubMed 28681996
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02033473
- Acronym / sponsor ID
- APELINS / 13 182 03
- Conditions
- Healthy
- Keywords
- Apelin, insulin, volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jan 2014 (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 (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.
Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apelin | Experimental | Drug: Apelin, Drug: PlaceboAn apelin clamp in which an apelin infusion will be administered prior to reference clamp |
| Placebo | Placebo comparator | Drug: Apelin, Drug: PlaceboA clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Men aged 18 to 40 years.
- BMI between 25 and 30 kg / cm ² (excluding terminals).
- Free of known chronic disease and any medication (any medication within 30 days prior to the inclusion visit).
- Non-pathological ECG.
- Heart rate between 50 and 80 beats per minute rest.
Key exclusion criteria (13 listed)
- Risk factor, treatment or ECG as recommended by International Conference on Harmonization E14 (ICH E14) "Clinical Evaluation of QT / corrected QT interval (QTc Interval= Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"
- Repeated a QTc interval> 450 ms measurement
- Risk factor: myocardial infarction, hypokalemia, family history of long QT syndrome
- Personal history of cancer.
- Positive HIV serology.
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 |
|---|---|---|
| ApelinAn apelin clamp in which an apelin infusion will be administered | Drug | Apelin, Placebo |
| PlaceboA clamp reference during which a placebo solution (saline solution) will be administered | Drug | Apelin, Placebo |
Primary outcome
Rate of glucose infusion
Time frame: The last 30 minutes of a hyperinsulinemic euglycemic clamp
Measuring the difference between the rate of glucose infusion measured in the last 30 minutes of a hyperinsulinemic euglycemic clamp in the presence of a continuous infusion (PYR1)-apelin-13 infusion rate of glucose measured in the same conditions in the presence of a continuous infusion of placebo.
11 secondary outcomes
Calculation of the index of insulin sensitivity (Si)
Time frame: During 240 minutes at visits 2 and 3
Changes in the measurement of systolic blood pressure during each clamp
Time frame: During 240 minutes at visits 2 and 3
Changes in the measurement of diastolic blood pressure during each clamp
Time frame: During 240 minutes at visits 2 and 3
Changes in heart rate measurement during each clamp
Time frame: During 240 minutes at visits 2 and 3
Changes in ECG during each clamp
Time frame: During 240 minutes at visits 2 and 3
Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4
Time frame: During 240 minutes at visits 2 and 3
Determination of plasma insulin at all sampling
Time frame: During 240 minutes at visits 2 and 3
Determination of plasma glucagon at all sampling times
Time frame: During 240 minutes at visits 2 and 3
Determination of plasma apelin at all sampling times
Time frame: During 240 minutes at visits 2 and 3
Determination of plasma leptin at all sampling times
Time frame: During 240 minutes at visits 2 and 3
Determination of plasma adiponectin at all sampling times
Time frame: During 240 minutes at visits 2 and 3
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 12 Jul 2019.
- Results publication: PubMed 28681996Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.
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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.
Pierre GOURDY, Md, PhD principal investigator
University Hospital of Toulouse
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 Apelin in people with Healthy, run by University Hospital, Toulouse at 1 site in France.
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 16 inclusion and 13 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 12 Jul 2019. 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 France. 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?
Rate of glucose infusion (time frame: The last 30 minutes of a hyperinsulinemic euglycemic clamp). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033473, which also lists 1 linked publication.
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 12 Jul 2019.