RECRUITING

Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

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Conditions

Non-Alcoholic Fatty Liver Disease

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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

This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.

Official Title

Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease

Quick Facts

Study Start:2025-01-27
Study Completion:2028-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06355310

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:16 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * For clinical referral to screening visit:
  2. * BMI \>30 kg/m2 or \>95th BMI-Percentile
  3. * Age 16 to \<21 at baseline
  4. * Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥ 44 U/L for girls, ≥ 50 U/L for boys)63 within 3 months prior to screening (used for historic ALT value) OR diagnosis of NAFLD from ultrasound, MRI, or participants with biopsy-proven NASH within 12 months of screening.
  5. * History of lifestyle modification to treat obesity or NAFLD.
  6. * Tanner stage \>2
  7. * Normal fasting glucose (fasting blood glucose \<100 mg/dL)
  8. * Confirmation of obesity;
  9. * Tanner stage 2,3,4 or 5;
  10. * Normal fasting glucose tolerance (fasting blood glucose \<100 mg/dL);
  11. * If Screening ALT is used as inclusion criteria (if \> 2x historic ALT value (historical value obtained clinically within 12 months of screening visit), repeated after 4 weeks \[unable to randomize until completed\]. If the repeat ALT is more than 50% increased or decreased over the screening ALT, a third ALT should be obtained. If a third ALT is not within 50% of the previous value, then the subject is ineligible but may be rescreened at a later date. If
  12. * ALT is not used:
  13. * An ultrasound will be done to diagnose NAFLD if the diagnosis has not previously been made by ultrasound, MRI or biopsy.
  14. * A MRI-derived HFF ≥ 5.5%
  15. * Willingness to adhere to lifestyle considerations throughout the study
  1. * •ALT \> 250U/L at screening
  2. * History of significant alcohol intake or current use
  3. * Impaired fasting glucose (\>100 mg/dL)
  4. * Diabetes (type 1 or 2)
  5. * Current or recent (\<6 months prior to enrollment) use of weight loss medication(s)
  6. * Vitamin E supplementation or use of metformin
  7. * Previous bariatric surgery
  8. * Prior use of empagliflozin
  9. * Lower limb infection/ulceration within 3 months of screening
  10. * Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible
  11. * Structural and functional urogenital abnormalities, that predispose for urogenital infections
  12. * Recent initiation (\<3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
  13. * Major psychiatric disorder
  14. * Known hypothalamic or pituitary dysfunction
  15. * Current pregnancy or plans to become pregnant
  16. * Females unwilling to be tested for pregnancy
  17. * Females who are sexually active and not protects by an effective method of birth control (e.g. UID or medication or patch)
  18. * Tobacco use
  19. * Significant liver dysfunction (levels \>5 times the upper limit of normal (ULN)):
  20. * ALT (ULN = 50 U/L)
  21. * AST (ULN = 48 U/L)
  22. * GGT (ULN = 48 U/L)
  23. * ALP (ULN = 115 U/L)
  24. * Platelets \< 150,000 cells/mm3
  25. * Total bilirubin 1.3 mg/dL
  26. * INR 1.3
  27. * Albumin \<3.2 g/dL
  28. * Gilbert's Syndrome
  29. * Any known causes of liver disease (except NAFLD and NASH)
  30. * Significant renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 80 mL/min/1.73 m2),
  31. * Diagnosed monogenic obesity
  32. * History of cancer
  33. * Untreated thyroid disorder
  34. * History of decompensation events (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma)
  35. * Current or recent (\<6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics).

Contacts and Locations

Study Contact

Angie Figueroa, MS, CCRP
CONTACT
773-550-0749
SHIELD@luriechildrens.org

Study Locations (Sites)

Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60601
United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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 Date2025-01-27
Study Completion Date2028-02-01

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2028-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Alcoholic Fatty Liver Disease