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NCT04934228 · ClinicalTrials.gov registry record · Phase 1
Mitigating the Pro-inflammatory Phenotype of Obesity
A Phase 1 study of Obesity and Diabetes, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04934228: Recruiting Phase 1 study of Obesity and Diabetes, sponsored by University of Kansas Medical Center.
NCT04934228 is a Phase 1 study of Obesity and Diabetes that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 60 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04934228, a Phase 1 study of Obesity and Diabetes, is actively recruiting participants, sponsored by University of Kansas Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.
Primary Outcome
Difference in inflammatory markers in blood compared with a BP-lowering control condition using hydrochlorothiazide (HCTZ) and a separate placebo treatment * Norepinephrine (inflammation) Blood Test: pg/mL normal range for norepinephrine is 70 to 1700 pg/mL * Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL normal values: IL-6 was 6-31 pg/mL and TNF-α 5 pg/mL, * Nitrotyrosine (Oxidative stress)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydrochlorothiazide 12.5Mg Tab
- DRUG Clonidine Pill
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 1 |
What NCT04934228 shows while recruiting
NCT04934228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower).
The record links to 6 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04934228 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT04934228 about?
NCT04934228 is a clinical study titled "Mitigating the Pro-inflammatory Phenotype of Obesity". The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a pro...
What is the current status of trial NCT04934228?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-07-01. Estimated completion is 2027-08-01.
What conditions does trial NCT04934228 study?
This clinical trial studies the following conditions: Obesity, Diabetes, Insulin Resistance, Blood Pressure, Diuretics Drug Reactions.
What interventions are being tested in trial NCT04934228?
The interventions under investigation include: Placebo (DRUG), Hydrochlorothiazide 12.5Mg Tab (DRUG), Clonidine Pill (DRUG).
Who is sponsoring clinical trial NCT04934228?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04934228 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04934228's enrollment target sits among peer trials
60 642nd of 1053 higher than 374 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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