Type 2 Diabetes (T2D) Clinical Trials

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Ketones, Muscle Metabolism, and SGLT2 Inhibitors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Type 2 Diabetes Mellitus

• Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%

• Age 18-80 years

• BMI 23-44 kg/m2

• Glycated hemoglobin (HbA1c) 6.0-10.0%

• Blood Pressure (BP) ≤ 145/85 mmHg

• Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2

• Only Type 2 diabetics treated with diet/exercise, metformin, sulfonylureas, metformin/sulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin

• Stable body weight (±4 pounds) over the previous 3 months prior to enrollment

• Ability to understand study procedures and to comply with them for the entire length of the study.

Locations
United States
Texas
Texas Diabetes Institute - University Health System
RECRUITING
San Antonio
Contact Information
Primary
Ralph DeFronzo, MD
defronzo@uthscsa.edu
210-567-6691
Backup
Sivaram Neppala, MD
neppalas@uthscsa.edu
210-358-7200
Time Frame
Start Date: 2024-01-25
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 71
Treatments
Experimental: Empagliflozin Group
Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
Placebo_comparator: Placebo group
Subjects will be randomized to receive the empagliflozin placebo for 3 months
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov