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 |
Trial Parameters
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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 bari
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