- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Eiveniu str. 2
-
Kaunas, Eiveniu str. 2, Litauen, LT50009
- Rasa Verkauskiene
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Control without Metformin
Conventional management of obesity including basic instructions on diet and physical activity
|
|
Eksperimentell: 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
Andre navn:
|
Eksperimentell: 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
Andre navn:
|
Ingen inngripen: Intervention without Metformin
Intensive physical activity course twice per week and monthly diet control by dietitian
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Body mass index changes
Tidsramme: 12 months
|
decrease in body mass index
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Glucose homeostasis
Tidsramme: 12 month
|
Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation
|
12 month
|
Lipid profile
Tidsramme: 12 months
|
Lipid profile normalisation
|
12 months
|
Metabolic syndrome
Tidsramme: 12 months
|
Metabolic syndrome prevalence and risks decrease
|
12 months
|
Hepatosteatosis
Tidsramme: 12 months
|
Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation
|
12 months
|
Polycystic ovary syndrome (PCOS) and hyperandrogenism in females
Tidsramme: 12 months
|
PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing
|
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
safety
Tidsramme: 12 months
|
how many patients will have adverse events and withdraw the Metformin due to their intolerance or clinical / biochemical relapse
|
12 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Rasa Verkauskiene, Professor, Lithuanian University of Health Sciences Hospital, Endocrinology Unit
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BE-2-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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