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Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers (APELINS)

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ClinicalTrials.gov Identifier: NCT02033473
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Apelin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Apelin
An apelin clamp in which an apelin infusion will be administered prior to reference clamp
Drug: Apelin
An apelin clamp in which an apelin infusion will be administered

Drug: Placebo
A clamp reference during which a placebo solution (saline solution) will be administered

Placebo Comparator: Placebo
A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp
Drug: Apelin
An apelin clamp in which an apelin infusion will be administered

Drug: Placebo
A clamp reference during which a placebo solution (saline solution) will be administered




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Calculation of the index of insulin sensitivity (Si) [ Time Frame: During 240 minutes at visits 2 and 3 ]
  2. Changes in the measurement of systolic blood pressure during each clamp [ Time Frame: During 240 minutes at visits 2 and 3 ]
  3. Changes in the measurement of diastolic blood pressure during each clamp [ Time Frame: During 240 minutes at visits 2 and 3 ]
  4. Changes in heart rate measurement during each clamp [ Time Frame: During 240 minutes at visits 2 and 3 ]
  5. Changes in ECG during each clamp [ Time Frame: During 240 minutes at visits 2 and 3 ]
  6. Clinical signs of intolerance / allergy / toxicity at visit 2,3 and 4 [ Time Frame: During 240 minutes at visits 2 and 3 ]
  7. Determination of plasma insulin at all sampling [ Time Frame: During 240 minutes at visits 2 and 3 ]
  8. Determination of plasma glucagon at all sampling times [ Time Frame: During 240 minutes at visits 2 and 3 ]
  9. Determination of plasma apelin at all sampling times [ Time Frame: During 240 minutes at visits 2 and 3 ]
  10. Determination of plasma leptin at all sampling times [ Time Frame: During 240 minutes at visits 2 and 3 ]
  11. Determination of plasma adiponectin at all sampling times [ Time Frame: During 240 minutes at visits 2 and 3 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033473


Locations
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France
University Hospital of Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Pierre GOURDY, Md, PhD University Hospital of Toulouse

Publications of Results:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02033473     History of Changes
Other Study ID Numbers: 13 182 03
HAO 2013 ( Other Identifier: Hors Appel d'Offres )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Keywords provided by University Hospital, Toulouse:
Apelin
insulin
volunteers
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs