Trial · NCT04374500
Leptin Infusion and Endothelial Vasomotor Response
NCT04374500, Early phase 1, Completed, Stefan Soderberg; results first posted 2020-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leptin Infusion and Endothelial Vasomotor Response. Trials, record NCT04374500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04374500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leptin Infusion and Endothelial Vasomotor Response
- NCT number
- NCT04374500
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 103 participants, actual
- Lead sponsor
- Stefan Soderberg
- Conditions
- Endothelial Dysfunction, Obesity, Vasodilation, Venous Occlusion Plethysmography
- Interventions
- Leptin infusion plus vasodilators in healthy men, Leptin infusion in healthy men, Vasodilators in CAD patients
- First posted
- 2020-05-05
- Last updated
- 2023-05-09
- Results first posted
- 2020-07-17
- Limitations and caveats
- Sympathetic activity should have been measured simultaneously, but was not done.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forearm Blood-flow (FBF) | 18 minutes in protocol 1, 3 hours in protocol 2, non-applicable (NA) in protocol 3 | 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. |
| Secondary | Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | 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. |
| Secondary | Leptin | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | 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. |
| Secondary | Systolic Blood Pressure | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | 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. |
| Secondary | Heart Rate | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | In all protocols, heart rate (beats per minute) was measured concomitantly. Heart rate is reported here after leptin or saline infusion, when applicable. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Forearm Blood-flow (FBF) | 18 minutes in protocol 1, 3 hours in protocol 2, non-applicable (NA) in protocol 3 | ml/100 mg tissue/min | MEAN | |
| SECONDARY | Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | IU/mL | MEAN | |
| SECONDARY | Leptin | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | In arm 3, the participants were not given any leptin, endogenous leptin was measured | ng/mL | MEAN |
| SECONDARY | Systolic Blood Pressure | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | mmHg | MEAN | |
| SECONDARY | Heart Rate | 18 minutes in protocol 1, 3 hours in protocol 2, NA in protocol 3 | Beats per minute | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Forearm Blood-flow (FBF) | Leptin Infusion, no Saline Given | Leptin infused | 1.75 | Standard Error 0.14 | ml/100 mg tissue/min |
| Forearm Blood-flow (FBF) | Leptin Plus Vasodilators | Leptin infused | 3.1 | Standard Error 0.4 | ml/100 mg tissue/min |
| Forearm Blood-flow (FBF) | Vasodilators in CAD Patients | Leptin infused | NA | Standard Error NA | ml/100 mg tissue/min |
| Forearm Blood-flow (FBF) | Leptin Infusion, no Saline Given | Saline infused | NA | Standard Error NA | ml/100 mg tissue/min |
| Forearm Blood-flow (FBF) | Leptin Plus Vasodilators | Saline infused | 3.4 | Standard Error 0.4 | ml/100 mg tissue/min |
| Forearm Blood-flow (FBF) | Vasodilators in CAD Patients | Saline infused | NA | Standard Error NA | ml/100 mg tissue/min |
| Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | Leptin Infusion | Leptin infused | 0.56 | Standard Error 0.12 | IU/mL |
| Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | Leptin Plus Vasodilators | Leptin infused | 0.91 | Standard Error 0.38 | IU/mL |
| Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | Vasodilators in CAD Patients | Leptin infused | NA | Standard Error NA | IU/mL |
| Release of Fibrinolytic Variables (Tissue Plasminogen Activator [tPA] and Plasminogen Activator Inhibitor-1 [PAI-1]) | Leptin Infusion | Saline infused | NA | Standard Error NA | IU/mL |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leptin Infusion in Healthy Men | 10 | |
| Overall Study | STARTED | Leptin or Saline Infusion Plus Vasodilators in Healthy Men | 10 | |
| Overall Study | STARTED | Vasodilators in CAD Patients | 83 | |
| Overall Study | COMPLETED | Leptin Infusion in Healthy Men | 10 | |
| Overall Study | COMPLETED | Leptin or Saline Infusion Plus Vasodilators in Healthy Men | 10 | |
| Overall Study | COMPLETED | Vasodilators in CAD Patients | 83 | |
| Overall Study | NOT COMPLETED | Leptin Infusion in Healthy Men | 0 | |
| Overall Study | NOT COMPLETED | Leptin or Saline Infusion Plus Vasodilators in Healthy Men | 0 | |
| Overall Study | NOT COMPLETED | Vasodilators in CAD Patients | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leptin Infusion | 0 | 10 |
| Total, all-cause mortality | Leptin Infusion Plus Vasodilator Infusion | 0 | 10 |
| Total, all-cause mortality | Saline Infusion Plus Vasodilator Infusion | 0 | 10 |
| Total, all-cause mortality | Vasodilator Infusion in CAD Patients | 0 | 83 |
| Total, other adverse events | Leptin Infusion | 0 | 10 |
| Total, other adverse events | Leptin Infusion Plus Vasodilator Infusion | 0 | 10 |
| Total, other adverse events | Saline Infusion Plus Vasodilator Infusion | 0 | 10 |
| Total, other adverse events | Vasodilator Infusion in CAD Patients | 0 | 83 |
| Total, serious adverse events | Leptin Infusion | 0 | 10 |
| Total, serious adverse events | Leptin Infusion Plus Vasodilator Infusion | 0 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40066842 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04374500
GET https://conductscience.org/api/trials/v1/NCT04374500/results?page=2