Obesity Clinical Trial
— LIVARMOfficial title:
The Effect of the Adipocyte-derived Hormone Leptin on Endothelial Function in Healthy Men and in Persons With Known Cardiovascular Disease
Verified date | July 2022 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | December 20, 2006 |
Est. primary completion date | October 27, 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion criteria protocol 1 and 2; - Healthy male - No regular medication - Non-smoking - Abstain from alcohol for 24 hours and from food, tobacco and caffeine-containing drinks for at least 4 hours before each study visit Inclusion criteria protocol 3; - Established coronary artery disease - Stable angina pectoris - Documented = 50% stenosis of at least one major epicardial coronary vessel Exclusion criteria protocol 3; - Coronary revascularisation within three months - Diabetes mellitus - Cardiac failure (ejection fraction <35% or New York Heart Association (NYHA) =2) - Renal impairment (creatinine =200 µmol/L) - Systolic blood pressure <100 or >190 mmHg |
Country | Name | City | State |
---|---|---|---|
Sweden | Umeå University Hopsital | Umeå | |
United Kingdom | British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
Stefan Soderberg | University of Edinburgh |
Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forearm Blood-flow (FBF) | The primary outcome in all protocols were local blood-flow in the forearm (FBF). This was measured by venous occlusion plethysmography using mercury-in-silastic strain gauges and the unit is mL/100mL of tissue/min. In protocol 1, the FBF response to increasing levels of leptin was evaluated, In protocol 2, the FBF response to vasodilators on top of leptin or saline infusion was evaluated, and in protocol 3, FBF was measured after infusion of vasodilators and no leptin was given. | 18 minutes in protocol 1, 3 hours in protocol 2, non-applicable (NA) in protocol 3 | |
Secondary | Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | In all protocols, fibrinolytic variables were measured. In protocol 2 and 3, in the infused forearm after vasodilatation with bradykinin or substance P, respectively.
The fibrinolytic variable measured in all protocols was tPA activity (IU/mL) and is reported here after the leptin infusion, when applicable. |
18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | |
Secondary | Leptin | Plasma leptin concentration (ng/mL) was measured in all protocols, and in protocol 1 and 2, specifically in both infused and in non-infused arms. Data given are leptin concentrations in the infused arm at the end of the infusion. | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | |
Secondary | Systolic Blood Pressure | In all protocols, blood pressure (mmHg) was measured concomitantly using a semi-automated non-invasive sphygmomanometer. Systolic blood pressure is reported here after leptin or saline infusion, when applicable. | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | |
Secondary | Heart Rate | In all protocols, heart rate (beats per minute) was measured concomitantly. Heart rate is reported here after leptin or saline infusion, when applicable. | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 |
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