Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)

Launched by CHILDREN'S HOSPITAL LOS ANGELES · Sep 1, 2020

Keywords

ClinConnect Summary

This clinical trial, called "Time Limited Eating in Adolescents With Type 2 Diabetes," is exploring how a specific eating plan, known as Time Limited Eating (TLE), can help young people with type 2 diabetes. The goal is to see if this eating pattern can improve blood sugar control, help the body’s insulin-producing cells work better, and reduce body fat and body mass index (BMI) in adolescents ages 12 to 21. The study is currently looking for participants, and all genders are welcome.

To participate, teens must have a diagnosis of type 2 diabetes and meet certain health criteria, such as having a hemoglobin A1c level below 9%. They should also be willing to follow the study's guidelines, which include specific eating and fasting schedules. However, some teens may not be eligible if they have certain medical conditions, previous eating disorders, or are currently taking certain medications. If eligible, participants can expect to follow the TLE plan and attend regular visits for assessments, helping researchers understand how this diet impacts their health. This study could provide important insights into managing diabetes in adolescents.

Gender

ALL

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.