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

14. august 2026 opdateret af: Hospices Civils de Lyon

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Bron, Frankrig, 69500
        • Hôpital-Femme-Mère-Enfant - Service d'endocrinologie et diabétologie pédiatrique
        • Kontakt:
        • Ledende efterforsker:
          • Carine Villanueva, Dr

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Adfærdsmæssigt: The primary intervention in this study is dietary counseling and education on adopting a low glycaemic index diet with sample menus provided

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

Enhed: continuous glucose monitoring (CGM) sensors

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Rate of Glycaemic Change (ROC) at Pre- and Post-prandial Time Points
Tidsramme: 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.
Day 0 to day 10 and Day 10 to day 20

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Glycaemic Variability Parameters
Tidsramme: 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
Day 0 to Day 10 and Day 10 to Day 20
Change in Satiety Scores
Tidsramme: 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.
Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
Tidsramme: Day 20
Correlation Between Glycaemic Parameters and Satiety Scores
Day 20

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospices Civils de Lyon

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

11. august 2026

Først indsendt, der opfyldte QC-kriterier

14. august 2026

Først opslået (Faktiske)

18. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 69HCL25_0864

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