University Hospitals of Toulouse (Rangueil)
Toulouse, Midi-Pyrénées, 31059, France
NCT Number: NCT02724566
Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.
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Notify Me40 year–65 year
Male
Interventional
Phase 1
Toulouse, Midi-Pyrénées, 31059, France
Insulin sensitivity is measured using the hyperinsulinemic euglycemic glucose clamp method. The hypothesis of the investigators is that a continuous (pyr1)-apelin-13 infusion improves insulin sensitivity of type 2 diabetic patients compared to placebo infusion.
This study could bring new elements for understanding the pathophysiology of insulin resistance and type 2 diabetes mellitus in humans and could lead to the development of innovative therapies in type 2 diabetes mellitus.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assessing the difference between the insulin sensitivity measured during hyperinsulinemic euglycemic clamps in the presence of a 2 hours continuous infusion of (PYR1)-apelin-13 (30nmol/kg) versus a 2 hours continuous infusion of placebo (vehicle alone).
Other names: [pyr1]-apelin-13 infusion
2 hours continuous infusion of placebo (vehicle alone) to compare with 2 hours infusion of apelin
Time frame: 240 minutes
Difference between glucose infusion rate measured during investigational product infusion (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and basal glucose infusion rate (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes).
Time frame: 240 minutes
Difference between value of product time (mean of values measured at 210, 215, 220, 225, 230, 235 and 240 minutes) and value of basal (mean of values measured at 90, 95, 100, 105, 110, 115 and 120 minutes).
Time frame: 240 minutes
Time frame: 240 minutes
Time frame: 240 minutes
Time frame: 240 minutes
Time frame: 240 minutes
A kinetic is realized with samples at 0, 15, 30, 45, 60, 75, 90, 100, 110, 120, 135, 150, 165, 180, 195, 200, 220, 230 and 240 minutes
Time frame: 240 minutes
Modification in physiological parameters
Time frame: 240 minutes
Modification in physiological parameters
University Hospital, Toulouse
Other
Influence of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers
Acronym: APELINS-2
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