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临床试验 NCT05031429 (TLET1D) 针对1型糖尿病目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Time Limited Eating in Type 1 Diabetes (TLET1D) 12 随机化 儿科
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临床试验NCT05031429 (TLET1D)是一项针对1型糖尿病的干预性研究试验，试验状态为已完成。试验开始于2022年1月1日，共计划招募12名患者。该研究由Children's Hospital Los Angeles主导，已于2023年6月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年8月16日。
简要概括
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, acce...显示更多
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...显示更多
官方标题
Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function
疾病
1型糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- TLET1D
- CHLA-21-00269
NCT编号
实际开始日期
2022-01-01
最近更新发布
2023-08-16
预计完成日期
2023-06-30
计划入组人数
12
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
已完成
关键词
Type 1 Diabetes
Time Limited Eating
β-cell
Time Limited Eating
β-cell
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Control - Standard Care * includes a minimum 12-hour feeding window for 7 days per week
* no caloric restriction will be used
* will wear a continuous glucose monitor | 不适用 |
实验性Intervention - Time Limited Eating * 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 | Time Limited Eating Includes an 8-hour feed/16-hour fast for 7 days per week, with consumption of all of calories in the afternoon/evening. Can consume non-caloric beverages (water, tea, coffee) during the fasting period. No caloric restriction will be used. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey" | 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. | At end of study (at 9 weeks) |
Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels | 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. | Baseline and 9 weeks |
Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c | 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. | Up to 9 weeks; HbA1c: Baseline and 9 weeks |
Safety, as indicated by hypoglycemia | 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. | Up to 9 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) | 24-hour dietary recall, \~30 minutes to complete. | Baseline, 9 weeks |
Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module | Likert scale "Never" is 0, "Almost Never" is 1, "Sometimes" is 2, "Often" is 3, and "Almost Always" is 4 | Baseline and 9 weeks |
Stress level, as indicated by Perceived Stress Scale | Likert scale "Never" is 0, "Almost Never" is 1, "Sometimes" is 2, "Fairly Often" is 3, and "Very Often" is 4 | Baseline and 9 weeks |
Binge Eating, as indicated by Binge Eating Disorder Screener | Likert scale "Never or rarely" is 0, "Sometimes" is 1, "Often" is 2, "Always" is 3. Additionally, two yes or no questions. | Baseline and 9 weeks |
Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form | Likert scale "Never" is 1, "Rarely" is 2, "Sometimes" is 3, "Often" is 4, "Always" is 5 | Baseline and 9 weeks |
Impact on activities of daily living, as indicated by Munich Chronotype Questionnaire (MCTQ) | Assessment of sleep schedule, school schedule, time spent outdoors. Multiple choice and open-ended questions. | Baseline and 9 weeks |
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
12 Years
适龄性别
全部
- 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
- negative pancreatic antibodies
- unwillingness to wear a CGM
Children's Hospital Los Angeles研究责任方
jennifer raymond, 主要研究者, Chief of the Division of Endocrinology, Principal Investigator, Children's Hospital Los Angeles
没有联系数据。
1 位于 1 个国家/地区的研究中心
California
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States