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Completed

NCT Number: NCT02033473

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

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.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital of Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apelin

Drug

An apelin clamp in which an apelin infusion will be administered

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: APELINS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2014
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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