Impact of a Targeted Nutritional Intervention on Glycaemic Variability
| Registry | NCT07771842, acronym APETIT |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 20 (Estimated) |
| Sponsor | Hospices Civils de Lyon (Other) |
| Conditions | Obesity in Adolescents |
| Interventions | 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 (Behavioral, device) |
| Dates | start 2026-10-01 (estimated), primary completion 2028-05-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-08-18, last updated 2026-08-18 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Obesity in Adolescents All trials of The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided All trials of continuous glucose monitoring (CGM) sensors
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Adolescents in obesity | Experimental | 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 | * 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 |
Sex: All, ages: 12 Years to 18 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hôpital-Femme-Mère-Enfant - Service d'endocrinologie et diabétologie pédiatrique | Bron | France |