- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01677923
Obesity in Children and Adolescents: Associated Risks and Early Intervention (OCA)
Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.
Panoramica dello studio
Descrizione dettagliata
During the first visit, study participants would follow the clinical investigation (anthropometry, physical examination, blood tests (hormonal and biochemical state), bioimpedance, ultrasound evaluation) and be attributed into 4 groups (matched for age, gender, pubertal stage and BMI), 100 subjects in each group.
- st group - control: during the first visit patients get standardized information on healthy lifestyle, diet and exercise. Next visit (control) will be scheduled for the clinical and laboratory evaluation after 12 months of intervention.
nd group - intensive diet and physical activity group: Children will be seen
- by a dietician once a month for diet re-evaluation;
- physical therapist, who will give physical activity course twice a week (1 h each).
- pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention.
rd group - intensive diet and physical activity group plus insulin sensitization: Metformin will be prescribed for this group of study children in the doses of 1000 mg/day Children will be seen by
- a dietician once a month for diet re-evaluation;
- physical therapist, who will give physical activity course twice a week (1 h each);
- pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention.
- th group- insulin sensitization without intensive diet and physical activity. Metformin will be prescribed in the doses of 1000 mg/day after standardized information on healthy lifestyle, diet and exercise during the first visit only. This group of children will be seen by pediatric endocrinologist every 3 months.
Intervention duration - 12 months. In the case of Metformin intolerance, children will continue the study in 2nd group.
Clinical and laboratory evaluation after 12 months of intervention.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Eiveniu str. 2
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Kaunas, Eiveniu str. 2, Lituania, LT50009
- Rasa Verkauskiene
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 10-17 yrs;
- Weight > 85th percentile for age and gender (by IOTF);
- Living in Kaunas and its region;
- No obvious chronic diseases;
- Not on steroid or other long-term treatment;
- Informed consent of the patient and parents (official caregivers);
Exclusion Criteria:
- Age less than 10 or above 17 yrs;
- Diagnosis of type 1 diabetes;
- Chronic illness that may affect physical activity and metabolic profile;
- Insulin treatment;
- Steroid treatment;
- Planning to move from Kaunas or its region in the period of 1 year;
- Protocol refused by the patient or his parents;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Control without Metformin
Conventional management of obesity including basic instructions on diet and physical activity
|
|
Sperimentale: Control with Metformin
Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment
|
Metformin 500 mg BID for 12 months
Altri nomi:
|
Sperimentale: Intervention with Metformin
Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment.
|
Metformin 500 mg BID for 12 months
Altri nomi:
|
Nessun intervento: Intervention without Metformin
Intensive physical activity course twice per week and monthly diet control by dietitian
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Body mass index changes
Lasso di tempo: 12 months
|
decrease in body mass index
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Glucose homeostasis
Lasso di tempo: 12 month
|
Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation
|
12 month
|
Lipid profile
Lasso di tempo: 12 months
|
Lipid profile normalisation
|
12 months
|
Metabolic syndrome
Lasso di tempo: 12 months
|
Metabolic syndrome prevalence and risks decrease
|
12 months
|
Hepatosteatosis
Lasso di tempo: 12 months
|
Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation
|
12 months
|
Polycystic ovary syndrome (PCOS) and hyperandrogenism in females
Lasso di tempo: 12 months
|
PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing
|
12 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
safety
Lasso di tempo: 12 months
|
how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse
|
12 months
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Rasa Verkauskiene, Professor, Lithuanian University of Health Sciences Hospital, Endocrinology Unit
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BE-2-1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Metformin
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Tan Tock Seng HospitalReclutamento