Obesity in AdolescentsAPETITNCT07771842
Impact of a Targeted Nutritional Intervention on Glycaemic Variability and Correlation Between Glycaemic Parameters and Satiety.
A study testing 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 people with Obesity in Adolescents, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity in Adolescents
- What is being tested?
- 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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Beaufils, Dr contact
France1 site
Hôpital-Femme-Mère-Enfant - Service d'endocrinologie et diabétologie pédiatrique
Bron, 69500
Carine Villanueva, Dr, 04.72.11.88.90, carine.villanueva@chu-lyon.fr
Carine Villanueva, Dr
About this study
Official title: 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.
- Conditions
- Obesity in Adolescents
- Being tested
- The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided, continuous glucose monitoring (CGM) sensors
- Keywords
- Obesity, low glycaemic index nutritional intervention, glycaemic variability, satiety
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus providedBehavioural
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
continuous glucose monitoring (CGM) sensorsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Adolescents in obesity | Experimental | * 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to day 10 and Day 10 to day 20
Secondary outcomes (3)
Change in Glycaemic Variability Parameters
Change in glycemic variability and CGM-derived glucose metrics from baseline to post-intervention
Measured: 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.
Measured: Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
Correlation Between Glycaemic Parameters and Satiety Scores
Measured: Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity in AdolescentsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, prospective, interventional clinical study (RIPH 2 - research involving human subjects outside of health products)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771842
- Sponsor's protocol ID
- 69HCL25_0864
- Acronym
- APETIT
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No