drugset / Trial / NCT04374500

Leptin Infusion and Endothelial Vasomotor Response

NCT04374500

Phase 0 Completed 103 enrolled Stefan Soderberg University of Edinburgh · collab
RandomizedCrossoverOpen-labelBasic science

Summary

Adipose tissue is an active endocrine organ producing several hormones with circulatory and metabolic effects. In 1994, the hormone leptin was discovered. The lack of this hormone explained extreme obesity in rare patients and parenteral substitution restored body weight and metabolic disturbances. It was however soon discovered that most humans had too high levels which were related to development of cardiovascular diseases and diabetes. It was hypothesised that leptin induced vessel dysfunction which could explain this association. In this study, we wanted to examine the association between leptin and vessel function by using the venous occlusion plethysmography method. We used three protocols to evaluate this association. First protocol. In ten healthy males, leptin was infused locally in the forearm and forearm blood flow (FBF) was measured. Second protocol. In ten healthy males, leptin or normal saline was infused locally in the forearm and FBF was measured. Concomitantly, four vasodilatators were infused locally in the forearm in a randomised order and the response (blood flow and fibrinolysis) was measured. Third protocol. In eighty-three patients with known coronary artery disease, three vasodilators were infused locally in the forearm in a random order and response (FBF and fibrinolysis) was measured. The response was related to endogenous leptin levels. The two first protocols were performed in Umeå, Sweden whereas the third was performed in Edinburgh, UK, all in 2006.

Timeline

Start
2006-01-01
Primary completion
2006-10-27
Completion
2006-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetylcholine Small molecule 5 ug Other
Subject Acetylcholine Small molecule 10 ug Other
Subject Acetylcholine Small molecule 20 ug Other
Subject Bradykinin Protein / enzyme biologic 100 unknown Other
Subject Bradykinin Protein / enzyme biologic 300 unknown Other
Subject Bradykinin Protein / enzyme biologic 1000 unknown Other
Subject Leptin Protein / enzyme biologic 80 ng
Subject Leptin Protein / enzyme biologic 800 ng
Subject Leptin Protein / enzyme biologic 8000 ng
Subject Sodium Nitroprusside Unknown 2 ug Other
Subject Sodium Nitroprusside Unknown 4 ug Other
Subject Sodium Nitroprusside Unknown 8 ug Other
Subject Substance P Small molecule 2 unknown Other
Subject Substance P Small molecule 4 unknown Other
Subject Substance P Small molecule 8 unknown Other
Subject Verapamil Other / unclassified 10 ug Other
Subject Verapamil Other / unclassified 30 ug Other
Subject Verapamil Other / unclassified 100 ug Other

Indications