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NCT03560323 · ClinicalTrials.gov registry record · Phase 1
Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1
A Phase 1 study of Heart Failure and Type 2 Diabetes Mellitus, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT03560323: Completed Phase 1 study of Heart Failure and Type 2 Diabetes Mellitus, sponsored by The University of Texas Health Science Center at San Antonio.
NCT03560323 is a Phase 1 study of Heart Failure and Type 2 Diabetes Mellitus that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 41 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03560323, a Phase 1 study of Heart Failure and Type 2 Diabetes Mellitus, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
Study Summary
To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).
Primary Outcome
Within 2 weeks after the screening visit, subjects return to the Research Institute (RII) at 7:00AM for a cardiac MRI on 3.0T MRI System (TIM, Trio, Siemens Medical Solution, Malvern, PA). Cardiac output (CO) is measured using velocity encoded phase contrast MRI. The patient lies in the MRI scanner, and the imaging plane is positioned perpendicular to the ascending aorta where blood flow can be measured accurately. The MRI scan is synchronized with the patient's heartbeats using ECG gating. Two
Conditions Studied
Interventions
- DRUG Beta-hydroxy-butyrate
Study Locations (2)
Texas
- Texas Diabetes Institute - University Health System - San Antonio
- University of Texas Health Science Center San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 1 |
What the finished NCT03560323 record still lists
NCT03560323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Beta-hydroxy-butyrate is the first listed.
NCT03560323 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03560323 about?
NCT03560323 is a clinical study titled "Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1". To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii...
What is the current status of trial NCT03560323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-01-07. Estimated completion is 2024-12-30.
What conditions does trial NCT03560323 study?
This clinical trial studies the following conditions: Heart Failure, Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT03560323?
The interventions under investigation include: Beta-hydroxy-butyrate (DRUG).
Who is sponsoring clinical trial NCT03560323?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03560323 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03560323's enrollment target sits among peer trials
41 305th of 397 higher than 93 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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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