Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"
研究概览
简要总结
This study is a randomized-control pilot study that aims to evaluate Time Limited Eating (TLE) in the pediatric T1D population, implemented within the first six months after diagnosis. This period is characterized by residual β-cell function, during which TLE may have the ability to preserve and improve β-cell activity, indicated by increased C-peptide production. The investigators aim to assess the feasibility, acceptability, and safety of TLE in the pediatric T1D population, as well as to investigate the impact of TLE on β-cell function, insulin sensitivity, and glycemic control.
详细描述
This will be a two-armed study with an intervention and control group. Feasibility and acceptability will be assessed by using questionnaires. Safety will be indicated by hypoglycemia occurrence. β-cell function and insulin sensitivity will be evaluated using mixed meal tolerance test with C-peptide and glucose levels. Glycemic control will be indicated by continuous glucose monitor (CGM). Block randomization will be utilized to ensure the groups are balanced in terms of BMI. The study period will be 9 weeks in duration, including a week-long run-in period and an 8-week intervention period. There will be two in-person study visits at week 0 and week 9. Anthropometrics including weight, height, and pubertal status will be evaluated at these times.
Group 1- Standard Care (control)
- includes a minimum 12-hour feeding window for 7 days per week
- no caloric restriction will be used
- will wear a continuous glucose monitor
Group 2 - TLE (intervention)
- includes an 8-hour feed/16-hour fast for 7 days per week
- will be instructed to consume all of their calories in the afternoon/evening period
- can consume non-caloric beverages (water, tea, coffee) during the fasting period
- will wear a continuous glucose monitor
- no caloric restriction will be used
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •includes age of 12-25 years
- •T1D diagnosed within 6 months
- •at least one positive pancreatic antibody including glutamic acid decarboxylase (GAD) antibody, islet tyrosine phosphatase 2 (IA2) antibody, or insulin antibody
- •can be on either insulin injections or insulin pump
- •can be of any BMI status
- •can speak any language
排除标准
- •negative pancreatic antibodies
- •unwillingness to wear a CGM
结局指标
主要结局
Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"
时间窗: At end of study (at 9 weeks)
Likert scale "Agree strongly" is 1, "Agree" is 2, "Neutral" is 3, "Disagree" is 4, and "Disagree strongly" is 5. Lower scores indicate more satisfaction, higher scores indicate low satisfaction.
Safety, as indicated by hypoglycemia
时间窗: Up to 9 weeks
Hypoglycemia will be defined as blood sugar \< 70 mg/dL on continuous glucose monitor. Frequency and severity of hypoglycemia will be used to assess safety of intervention.
Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels
时间窗: Baseline and 9 weeks
C-peptide and glucose levels will be performed at baseline and 60-, 90-, and 120-minutes post-meal. Baseline plasma C-peptide concentration divided by the baseline plasma glucose concentration will be calculated as a pragmatic marker of β-cell function. The area under the stimulated C-peptide curve will then be calculated, which will be the primary outcome examined.
Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c
时间窗: Up to 9 weeks; HbA1c: Baseline and 9 weeks
Continuous glucose monitors will be worn for duration of the study, glycemic control will be evaluated using percent time in range. HbA1c will reflect glycemic control over time.
次要结局
- Binge Eating, as indicated by Binge Eating Disorder Screener(Baseline and 9 weeks)
- Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form(Baseline and 9 weeks)
- Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)(Baseline, 9 weeks)
- Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module(Baseline and 9 weeks)
- Stress level, as indicated by Perceived Stress Scale(Baseline and 9 weeks)
- Impact on activities of daily living, as indicated by Munich Chronotype Questionnaire (MCTQ)(Baseline and 9 weeks)
研究者
jennifer raymond
Chief of the Division of Endocrinology, Principal Investigator
Children's Hospital Los Angeles