- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Eiveniu str. 2
-
Kaunas, Eiveniu str. 2, Litauen, LT50009
- Rasa Verkauskiene
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control without Metformin
Conventional management of obesity including basic instructions on diet and physical activity
|
|
Eksperimentel: 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 navne:
|
Eksperimentel: 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 navne:
|
Ingen indgriben: Intervention without Metformin
Intensive physical activity course twice per week and monthly diet control by dietitian
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body mass index changes
Tidsramme: 12 months
|
decrease in body mass index
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Rasa Verkauskiene, Professor, Lithuanian University of Health Sciences Hospital, Endocrinology Unit
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BE-2-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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