Type 2 Diabetes Clinical Trial
Official title:
Impact of Meal Timing on Glycemic Profiles in Adolescents With Type 2 Diabetes
Because of its simplicity, TLE may represent a more feasible approach for adolescents than other caloric restriction regimens based on macronutrient composition and kilocalories. Our preliminary data support TLE feasibility, acceptability, and safety in adolescents with obesity, with and without T2D. However, no trial to date has studied the effects of TLE on glycemic control and body composition in adolescents with T2D. Our long-term goal is to determine whether TLE is a beneficial as part of the medical regimen early in diagnosis in adolescents living with T2D, and if so, to identify: 1) participant characteristics associated with positive response, 2) mechanisms by which TLE operates, and 2) the best methods to administer TLE to maximally harness its effects. Therefore, the aim of this study will be to compare cardiometabolic effects of TLE (8-hr eating period/16-hr of daily fasting) versus a prolonged eating period (12+hour eating period) in a randomized pilot study with careful control of timely compliance, dietary composition, calorie intake, and physical activity to accurately capture the dosage of the intervention received. We hypothesize that TLE will minimize glycemic excursions, delay β-cell deterioration, and reduce body fat mass in adolescents with T2D when compared to prolonged eating periods. One-hundred adolescents with T2D will be recruited. All participants will be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: >12-hour eating period or (2) TLE.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2027 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Binge eating disorder screen | The 7 item Binge-Eating Disorder Screener is a brief screener for BED, can assist physicians in identifying patients who may have BED and making the necessary follow-up decisions related to patient referrals or additional assessment and potential diagnosis of BED. | Measured at week 0,4, 12 | |
Other | Adult eating behavior Questionnaire | The AEBQ will be used to assess participants' approach to food and eating along three dimensions: emotional, external, and restrained eating. There is a high degree of stability for each of these three eating behavior scales. The DEBQ has high internal consistency and validity. We will compare changes in DEBQ scores across study arms to monitor possible iatrogenic effects of TLE. | Measured at week 0,4, 12 | |
Primary | Change in percent time in range | Change in percent time in range, as measured on CGM over the study period | Measured at week 0,4, 12 | |
Primary | Change in Hemoglobin A1c | Change in hemoglobin A1c at week 12 compared to baseline | Week 12 compared to baseline | |
Primary | Change in insulinogenic index | Change in insulinogenic index after mixed meal tolerance test | Week 12 compared to baseline | |
Primary | Change in total body fat mass (kg) | Change in total body fat mass as measured by DEXA at week 12 compared to baseline | Week 12 compared to baseline | |
Secondary | ASA 24 Dietary Recall | Twenty-four-hour dietary recalls will be conducted for all participants pre- and post-intervention. One weekday and one weekend day will be collected for all participants. | Measured at week 0,4, 12 | |
Secondary | International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire (IPAQ) has been developed to estimate levels of habitual physical activity across different countries and socio-cultural environments and will be collected at 5 time points. | Measured at week 0,4, 12 | |
Secondary | Munich Chronotype Questionnaire for children and adolescents (MTCQ) | The Munich ChronoType Questionnaire (MCTQ) is a self-rated scale to assess sleep structure, patterns, duration, and quality and will be collected at 5 time points. | Measured at week 0,4, 12 | |
Secondary | Pittsburg Sleep Quality Index | PSI self-reported sleep scale of quality and quantity | Measured at week 0,4, 12 | |
Secondary | Change in BMI in excess of the 95th percentile (%BMIp95) | Change in %BMIp95 | Measured at week 0,4, 12 |
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