Time Limited Eating for Adolescents with Type 2 Diabetes
Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
This study is testing if a Time Limited Eating diet can help Latinx teens with type 2 diabetes improve their blood sugar control and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04536480 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the effectiveness of a Time Limited Eating (TLE) diet plan on glycemic control, β-cell function, and body composition in adolescents with type 2 diabetes. The study will recruit 100 predominantly Latinx adolescents from Children's Hospital Los Angeles, who will be randomized into two groups: one following an 8-hour eating window and the other with a 12-hour or more eating period. All participants will receive standard nutritional counseling and use a continuous glucose monitor to track their progress over 12 weeks.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-21 years with a diagnosis of type 2 diabetes and a hemoglobin A1c level below 9%.
Not a fit: Patients with certain medical conditions, such as Prader-Willi Syndrome or eating disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve glycemic control and overall health outcomes for adolescents with type 2 diabetes.
How similar studies have performed: While the concept of time-restricted eating is gaining attention, this specific approach in adolescents with type 2 diabetes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Alaina Vidmar, MD — Children's Hospital Los Angeles
- Study coordinator: Alaina Vidmar, MD
- Email: avidmar@chla.usc.edu
- Phone: 323-361-3385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.