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Ketone

Beta-hydroxybutyrate for Type 2 Diabetes (Protocol1 Trial)

Phase 1
Recruiting
Led By Ralph A DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %
Type 2 diabetes
Must not have
Women who are pregnant or breastfeeding
Treatment with Glucagon-like peptide-1 receptor agonist (GLP-1 RA), Dipeptidyl peptidase-4 inhibitors (DPP4i), pioglitazone, SGLT2 inhibitor or insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 300-360 minutes after the start of infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the effects of increasing levels of beta-hydroxybutyrate on heart function in type 2 diabetic patients.

Who is the study for?
This trial is for adults aged 18-80 with Type 2 diabetes and heart failure (Class II-III NYHA) who have an ejection fraction below 50%. Participants should have a BMI of 23-38, stable blood pressure, and specific levels of HbA1c and NT-proBNP. Those on certain diabetes medications or with conditions that could risk safety or affect results can't join.
What is being tested?
The study tests how different levels of beta-hydroxy-butyrate (B-OH-B), a ketone body, affect heart muscle function and sugar uptake in the heart using advanced imaging techniques like cardiac MRI and PET scans in people with Type 2 diabetes suffering from heart failure.
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions to substances used during MRI or PET scans, changes in blood sugar levels due to B-OH-B infusion, or discomfort at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is reduced, and I have some limitations on physical activity.
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I have type 2 diabetes.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I am currently taking medication for diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~300-360 minutes after the start of infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 300-360 minutes after the start of infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiac Function
Secondary study objectives
Myocardial energetics

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Group I Beta-Hydroxy-ButyrateActive Control1 Intervention
Administration of beta-hydroxy-butyrate at 0.4 mg/kg.min for 20 minutes and then at a constant rate of 0.2 mg/kg.min until study end
Group II: Group II Beta-Hydroxy-ButyrateActive Control1 Intervention
Administration of beta-hydroxy-butyrate at 1.5 mg/kg.min for 20 minutes and then at a constant rate of 0.75 mg/kg.min until study end
Group III: Group III Beta-Hydroxy-ButyrateActive Control1 Intervention
Administration of beta-hydroxy-butyrate at 4.0 mg/kg.min for 20 minutes and then at a constant rate of 2.0 mg/kg.min until study end

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,897 Total Patients Enrolled
5 Trials studying Heart Failure
227 Patients Enrolled for Heart Failure
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,341 Total Patients Enrolled
7 Trials studying Heart Failure
425 Patients Enrolled for Heart Failure
Ralph A DeFronzo, MDPrincipal InvestigatorUT Health San Antonio
9 Previous Clinical Trials
1,078 Total Patients Enrolled
1 Trials studying Heart Failure
78 Patients Enrolled for Heart Failure

Media Library

Beta-hydroxy-butyrate (Ketone) Clinical Trial Eligibility Overview. Trial Name: NCT03560323 — Phase 1
Heart Failure Research Study Groups: Group I Beta-Hydroxy-Butyrate, Group II Beta-Hydroxy-Butyrate, Group III Beta-Hydroxy-Butyrate
Heart Failure Clinical Trial 2023: Beta-hydroxy-butyrate Highlights & Side Effects. Trial Name: NCT03560323 — Phase 1
Beta-hydroxy-butyrate (Ketone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03560323 — Phase 1
~19 spots leftby Oct 2026
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