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

Toulouse University Hospital

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Apelin

Study type: Interventional

Funder types: Other

Identifiers

NCT02033473

13 182 03

HAO 2013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Apelin

Experimental group

Description:

An apelin clamp in which an apelin infusion will be administered prior to reference clamp

Treatment:

Drug: Placebo

Drug: Apelin

Placebo

Placebo Comparator group

Description:

A clamp reference during which a placebo solution (saline solution) will be administered prior to apelin clamp

Treatment:

Drug: Placebo

Drug: Apelin