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COMPLETED Phase 1

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

NCT03560323 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 41 participants
Start Date 2019-01-07
Est. Completion 2024-12-30
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03560323

The ClinicalTrials.gov registry entry for NCT03560323 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 481 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03560323 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03560323?

The interventions under investigation include: Beta-hydroxy-butyrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03560323?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 481 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial