An interventional study of The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided and continuous glucose monitoring (CGM) sensors in Obesity in Adolescents, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 20 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Behavioral: The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided · Device: continuous glucose monitoring (CGM) sensors
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
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
Change in Rate of Glycaemic Change (ROC) at Pre- and Post-prandial Time Points
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 Glycaemic Variability Parameters
Change in glycemic variability and CGM-derived glucose metrics from baseline to post-intervention
Time frame: Day 0 to Day 10 and Day 10 to Day 20
Change in Satiety Scores
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
Correlation Between Glycaemic Parameters and Satiety Scores
Time frame: Day 20
Start is estimated for Dec 2026; primary completion for Jul 2028, 19 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 19 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: start Oct 2026 → Dec 2026, primary completion May 2028 → Jul 2028 and completion May 2028 → Jul 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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