Back to resultsEffect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers (APELINS)
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Apelin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Apelin, insulin, volunteers
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- University Hospital of Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Apelin
Placebo
Arm Description
An apelin clamp in which an apelin infusion will be administered prior to reference clamp
A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Calculation of the index of insulin sensitivity (Si)
Changes in the measurement of systolic blood pressure during each clamp
Changes in the measurement of diastolic blood pressure during each clamp
Changes in heart rate measurement during each clamp
Changes in ECG during each clamp
Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4
Determination of plasma insulin at all sampling
Determination of plasma glucagon at all sampling times
Determination of plasma apelin at all sampling times
Determination of plasma leptin at all sampling times
Determination of plasma adiponectin at all sampling times
Full Information
NCT ID
NCT02033473
First Posted
December 12, 2013
Last Updated
July 10, 2019
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02033473
Brief Title
Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
Acronym
APELINS
Official Title
Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Apelin, insulin, volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apelin
Arm Type
Experimental
Arm Description
An apelin clamp in which an apelin infusion will be administered prior to reference clamp
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp
Intervention Type
Drug
Intervention Name(s)
Apelin
Intervention Description
An apelin clamp in which an apelin infusion will be administered
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A clamp reference during which a placebo solution (saline solution) will be administered
Primary Outcome Measure Information:
Title
Rate of glucose infusion
Description
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.
Time Frame
The last 30 minutes of a hyperinsulinemic euglycemic clamp
Secondary Outcome Measure Information:
Title
Calculation of the index of insulin sensitivity (Si)
Time Frame
During 240 minutes at visits 2 and 3
Title
Changes in the measurement of systolic blood pressure during each clamp
Time Frame
During 240 minutes at visits 2 and 3
Title
Changes in the measurement of diastolic blood pressure during each clamp
Time Frame
During 240 minutes at visits 2 and 3
Title
Changes in heart rate measurement during each clamp
Time Frame
During 240 minutes at visits 2 and 3
Title
Changes in ECG during each clamp
Time Frame
During 240 minutes at visits 2 and 3
Title
Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4
Time Frame
During 240 minutes at visits 2 and 3
Title
Determination of plasma insulin at all sampling
Time Frame
During 240 minutes at visits 2 and 3
Title
Determination of plasma glucagon at all sampling times
Time Frame
During 240 minutes at visits 2 and 3
Title
Determination of plasma apelin at all sampling times
Time Frame
During 240 minutes at visits 2 and 3
Title
Determination of plasma leptin at all sampling times
Time Frame
During 240 minutes at visits 2 and 3
Title
Determination of plasma adiponectin at all sampling times
Time Frame
During 240 minutes at visits 2 and 3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre GOURDY, Md, PhD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28681996
Citation
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.
Results Reference
result
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Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
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