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Impact of a Targeted Nutritional Intervention on Glycaemic Variability and Correlation Between Glycaemic Parameters and Satiety. (APETIT)

2026年8月14日 更新者：Hospices Civils de Lyon

Impact of a Targeted Nutritional Intervention on Glycaemic Variability

Obesity affects 18% of French adults and increasingly impacts adolescents. Dietary management is challenging, particularly with eating disorders like hyperphagia. The study hypothesizes that glycaemic variability contributes to eating disorders, as blood glucose fluctuations and reactive hypoglycaemia may exacerbate compulsive eating. Currently, no data exists on the relationship between glycaemic profile and satiety in obese adolescents.

This exploratory study will establish foundation for larger research evaluating glucose sensors as therapeutic education tools in obesity management, helping patients understand diet-satiety relationships.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Bron、法国、69500
        • Hôpital-Femme-Mère-Enfant - Service d'endocrinologie et diabétologie pédiatrique
        • 接触：
        • 首席研究员：
          • Carine Villanueva, Dr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adolescents who have entered puberty (Tanner S2+ or G2+)
  • Aged over 12 and under 18 years
  • Obese, defined by an IOTF Body Mass Index (BMI) > 30
  • Child's assent and consent from the person(s) exercising parental authority

Exclusion Criteria:

  • Type 2 diabetes: HbA1c > 6.5% or fasting plasma glucose > 1.26 g/L
  • Type 1 diabetes
  • Treatment capable of altering the glycemic profile (e.g., corticosteroids)
  • Intercurrent illness capable of significantly impacting eating behavior (e.g., Prader-Willi syndrome) or the postprandial glycemic profile
  • Hypothalamic obesity
  • Neuropsychomotor developmental disorders, intellectual disability
  • History of bariatric surgery
  • Pregnant, parturient, or breastfeeding women
  • Persons deprived of liberty by a judicial or administrative decision
  • Persons undergoing psychiatric care
  • Persons admitted to a healthcare or social care facility for purposes other than the research
  • Adults subject to a legal protection measure (guardianship, curatorship)
  • Persons not affiliated with a social security scheme or beneficiaries of a similar scheme
  • Participation in a study affecting appetite or blood glucose levels

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Adolescents in obesity
  • Adolescents who have begun puberty (Tanner S2+ or G2+)
  • Aged over 12 and under 18
  • Obese, defined by a Body Mass Index (BMI) IOTF > 30
行为的：The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided

At Day 14, participants receive dietary counseling from a department dietician focusing on a low glycaemic index diet. The intervention includes:

  • Education on low glycaemic index food choices
  • Provision of sample menus demonstrating low glycaemic index meal planning
  • Guidance on implementing dietary changes to reduce glycaemic variability The intervention aims to modify eating behaviors by teaching participants to select foods that produce smaller, more gradual increases in blood glucose levels, potentially reducing glycaemic excursions and improving satiety.

Duration of intervention effect: 10 days (from Day 10 to Day 20) Monitoring: Participants maintain a food diary recording meal times and food types throughout the study period (Day 0 to Day 20). Continuous glucose monitoring is used to assess glycaemic response before (Day 0-10) and after (Day 10-20) the dietary intervention.

Note: The placement of two CGM sensors serves as a

设备：continuous glucose monitoring (CGM) sensors

Description:

Placement of continuous glucose monitoring (CGM) sensors on the back of the participant's dominant arm.

Two sensors are placed during the study:

  • First sensor: Placed at Day 0, worn for 10 days (baseline period)
  • Second sensor: Placed at Day 10 worn for 10 days (post-intervention period) The CGM measures interstitial fluid glucose concentrations in the range of 40 to 500 mg/dL every 5 minutes for 10 days per sensor.

Procedure: Sensors are placed according to manufacturer's recommendations. Participants receive general instructions on sensor maintenance and hygiene.

Purpose: The sensors cross the skin barrier to continuously monitor glucose levels, providing data on:

  • Glycaemic variability (rate of change, coefficient of variation)
  • Time in range (70-140 mg/dL)
  • Time in hypoglycaemia (<70 mg/dL)
  • Time in hyperglycaemia (>140 mg/dL)
  • Average glucose levels
  • Glycaemic excursions

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Rate of Glycaemic Change (ROC) at Pre- and Post-prandial Time Points
大体时间：Day 0 to day 10 and Day 10 to day 20
Difference in the rate of change (ROC) in blood glucose levels (mg/dL/min) measured at each pre-prandial and post-prandial time point, comparing the baseline period (Day 0-10) to the post-intervention period (Day 10-20). ROC is calculated from continuous glucose monitoring data collected every 5 minutes. The change will be analyzed using paired statistical tests comparing mean ROC values before and after dietary intervention.
Day 0 to day 10 and Day 10 to day 20

次要结果测量

结果测量
措施说明
大体时间
Change in Glycaemic Variability Parameters
大体时间：Day 0 to Day 10 and Day 10 to Day 20
Change in glycemic variability and CGM-derived glucose metrics from baseline to post-intervention
Day 0 to Day 10 and Day 10 to Day 20
Change in Satiety Scores
大体时间：Day 20
Change in subjective satiety from baseline (before dietary intervention) to post-intervention, assessed using a Visual Analogue Scale (VAS; 0-100 mm) and the Satiety Labeled Intensity Magnitude (SLIM) Scale.
Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
大体时间：Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
Day 20

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospices Civils de Lyon

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年8月11日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 69HCL25_0864

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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