Hôpital-Femme-Mère-Enfant - Service d'endocrinologie et diabétologie pédiatrique
Bron, 69500, France
NCT Number: NCT07771842
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.
Trial opening soon.
Get Notified12 year–18 year
All sexes
Interventional
Not applicable
Bron, 69500, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At Day 14, participants receive dietary counseling from a department dietician focusing on a low glycaemic index diet. The intervention includes:
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
Description:
Placement of continuous glucose monitoring (CGM) sensors on the back of the participant's dominant arm.
Two sensors are placed during the study:
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:
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
Trial opening soon.
Get NotifiedHospices Civils de Lyon
Other
Impact of a Targeted Nutritional Intervention on Glycaemic Variability
Acronym: APETIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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