Impact of a Targeted Nutritional Intervention on Glycaemic Variability and Correlation Between Glycaemic Parameters and Satiety.
Obesity in Adolescents
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 12 years - 18 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 20 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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
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
The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided BEHAVIORAL
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) sensors DEVICE
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
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change in Rate of Glycaemic Change (ROC) at Pre- and Post-prandial Time Points
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.
Secondary measures
Change in Glycaemic Variability Parameters
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
Change in Satiety Scores
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.
Correlation Between Glycaemic Parameters and Satiety Scores
Time frame: Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Hôpital-Femme-Mère-Enfant - Service d'endocrinologie et diabétologie pédiatriqueBron, FranceStatus unknown
Study team and timeline
- Lead sponsor
- Hospices Civils de Lyon
- Study start
- Dec 1, 2026 Estimated
- Primary completion
- Jul 1, 2028 Estimated
- Study completion
- Jul 1, 2028 Estimated
- First posted
- Aug 18, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Impact of a Targeted Nutritional Intervention on Glycaemic Variability
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026