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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 300-360 minutes after the start of infusion
Awards & highlights
Protocol1 Trial 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.Check my eligibility
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.See study design
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.
Protocol1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is reduced, and I have some limitations on physical activity.
Select...
I have type 2 diabetes.
Select...
I am between 18 and 80 years old.
Protocol1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 300-360 minutes after the start of infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~300-360 minutes after the start of infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac Function
Secondary outcome measures
Myocardial energetics
Protocol1 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
452 Previous Clinical Trials
91,350 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
2,348 Previous Clinical Trials
4,314,654 Total Patients Enrolled
6 Trials studying Heart Failure
350 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 23 and 38.My heart's pumping ability is reduced, and I have some limitations on physical activity.I am not pregnant or breastfeeding.Your HbA1c level is between 6.0% and 9.0%.Your blood pressure is lower than 145/85 mmHg.Your kidney function is good, with an eGFR above 30.I have type 2 diabetes.I am between 18 and 80 years old.Your NT-proBNP level is higher than 500 pg/mL (or higher than 300 pg/mL if your heart's ejection fraction is less than 35%).I am currently taking medication for diabetes.You have metal objects in your body that can't be removed for an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Group I Beta-Hydroxy-Butyrate
- Group 2: Group II Beta-Hydroxy-Butyrate
- Group 3: Group III Beta-Hydroxy-Butyrate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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