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Search / Trial NCT06902077

A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 27, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Pediatric Type 2 Diabetes Type 2 Diabetes Low Carb Diet Low Carbohydrate Dietary

ClinConnect Summary

Background Type 2 diabetes (T2D) in teenagers is becoming a growing health concern. In the U.S., the number of children and teens diagnosed with T2D nearly doubled between 2002 and 2018. Experts predict that in the next 40 years, the number of young people with T2D could quadruple.

T2D in youth is different from T2D in adults. Teens with T2D have more insulin resistance and their bodies struggle to make enough insulin. Unfortunately, common diabetes medications do not stop the disease from getting worse. Better treatment options for young people with T2D are needed.

T2D happens when the b...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 12-18
  • Diabetes diagnosis \>3 months to ensure stable baseline glycemic control
  • HbA1C between 6.5- 8.5%
  • BMI \>85th percentile
  • Negative pancreatic autoantibodies
  • Stable dose of anti-diabetic drugs GLP-1, metformin, SGLT-2 inhibitors, for 3 months
  • Exclusion Criteria:
  • Current insulin treatment
  • Renal impairment measured as creatinine \> 1 mg/dL
  • Hepatic dysfunction measured as AST and ALT \>100 IU/ml

Trial Officials

Ortal Resnick, MD

Principal Investigator

University of Alabama at Birmingham

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported