NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Impact of a Targeted Nutritional Intervention on Glycaemic Variability and Correlation Between Glycaemic Parameters and Satiety.

NCT07771842

Not Yet RecruitingNA

Sponsor: Hospices Civils de Lyon

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

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Bron, France