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

Summary

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.

Conditions

• Obesity in Adolescents

Interventions

BEHAVIORAL

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

DEVICE

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

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2028-05-01

Completion

2028-05-01

Countries

• France

Study Locations