NCT04536480 Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
| NCT ID | NCT04536480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Los Angeles |
| Condition | Pediatric Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-15 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-04-15 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To find the effectiveness of a diet plan (Time Limited Eating or TLE) on glycemic control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes.
Eligibility Criteria
All adolescents with T2D and referred to the endocrinology clinic at CHLA will be screened. Inclusion criteria are: (1) age 12-21 years; (2) Tanner stage III and above; (3) diagnosis of T2D based on the ADA diagnostic guidelines; (4) hemoglobin A1c \< 9%; and (5) participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods. To limit confounding factors, individuals will be considered ineligible to participate if they meet any of the following exclusion criteria: (1) previous diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity; (2) serious developmental or intellectual disability; (3) previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder); (4) parent/guardian-reported physical, mental of other inability to participate in the assessments (e.g., inability to wear CGM, inability to undergo imaging testing without sedation); (5) previous or planned bariatric surgery; (6) current planned use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, glucagon-like-peptide-1 agonist, naltrexone, or bupropion); or (7) current participation in other interventional weight loss studies.
Contact & Investigator
Alaina Vidmar, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Los Angeles
Frequently Asked Questions
Who can join the NCT04536480 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying Pediatric Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04536480 currently recruiting?
Yes, NCT04536480 is actively recruiting participants. Contact the research team at avidmar@chla.usc.edu for enrollment information.
Where is the NCT04536480 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04536480 clinical trial?
NCT04536480 is sponsored by Children's Hospital Los Angeles. The principal investigator is Alaina Vidmar, MD at Children's Hospital Los Angeles. The trial plans to enroll 100 participants.
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