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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 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.

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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).

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

What the Registry Record Tells You About NCT03560323

The ClinicalTrials.gov registry entry for NCT03560323 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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

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