RECRUITING

SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

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Conditions

Type 2 DiabetesPancreatic clampEndogenous glucose productionKetogenesisGluconeogenesisLipolysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To examine the 2-HIT hypothesis that the SGLT2i-induced stimulation of EGP, lipolysis, and ketone production requires the combination of volume depletion plus insulinopenia in T2D individuals.

Official Title

Protocol III: SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia

Quick Facts

Study Start:2025-04-29
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07053306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 30-75 years
  2. * Body Mass Index (BMI) 21-45 kg/m2
  3. * Hemoglobin A1C (HbA1c) = 7.0-11%
  4. * Estimated glomerular filtration rate (eGFR) \> 60 ml/min/1.73m2
  5. * Blood Pressure (BP) \< 160/90 mmHg
  6. * Participants must be in general good health based on medical history, physical exam, screening blood chemistries, complete blood chemistry (CBC), thyroid stimulating hormone/thyroxine (TSH/T4), electrocardiogram (EKG), and urinalysis
  7. * Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program
  8. * Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU/MET
  9. * Statin therapy is permissible if the dose has been stable for at least 3 months
  1. * Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded
  2. * Patients taking medications (other than SU/MET) known to affect glucose metabolism are excluded
  3. * Subjects with evidence of proliferative retinopathy or eGFR \< 60 are excluded
  4. * Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices

Contacts and Locations

Study Contact

Ralph DeFronzo, MD
CONTACT
210-567-6691
defronzo@uthscsa.edu
Aurora Merovci, MD
CONTACT
210-567-6691
merovci@uthscsa.edu

Principal Investigator

Ralph DeFronzo, MD
PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio

Study Locations (Sites)

Texas Diabetes Institute/UH
San Antonio, Texas, 78229-3900
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Ralph DeFronzo, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic clamp
  • Endogenous glucose production
  • Ketogenesis
  • Gluconeogenesis
  • Lipolysis

Additional Relevant MeSH Terms

  • Type 2 Diabetes