CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 103 enrolled
Drug / intervention
Leptin infusion plus vasodilators in healthy men +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04374500
NCT04374500Early Ph 1Completed

The Effect of the Adipocyte-derived Hormone Leptin on Endothelial Function in Healthy Men and in Persons With Known Cardiovascular Disease

Stefan Soderberg·interventional·Posted May 5, 2020·Updated May 9, 2023

In Brief

A Early Phase 1 clinical trial evaluating Leptin infusion plus vasodilators in healthy men, Leptin infusion in healthy men, and 1 other intervention for Endothelial Dysfunction and 3 related conditions. Completed, enrolled 103 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden, United Kingdom

Timeline

Early Ph 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2020
Enrollment StartJan 1, 2006
Primary CompletionOct 27, 2006
Study CompletionDec 20, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.2 years ago

Interventions

Leptin infusion plus vasodilators in healthy mendrug

This applies only to protocol 2 with two arms (leptin or saline) where four vasodilatators (bradykinin, acetylcholine, sodium nitroprusside and verapamil) were infused concomitantly

Leptin infusion in healthy mendrug

This applies only to protocol 1 when only leptin was given

Vasodilators in CAD patientsdrug

This applies only to protocol 3