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Obesity in Children and Adolescents: Associated Risks and Early Intervention (OCA)

2. marts 2016 opdateret af: Rasa Verkauskiene, Lithuanian University of Health Sciences

Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.

The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and increases insulin sensitivity; the study team hope to get better effect of weight decrease and metabolic processes repair in the intensive treatment group with intervention of physical activity, diet correction and Metformin use.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

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.

  1. 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.
  2. nd group - intensive diet and physical activity group: Children will be seen

    1. by a dietician once a month for diet re-evaluation;
    2. physical therapist, who will give physical activity course twice a week (1 h each).
    3. pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention.
  3. 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

    1. a dietician once a month for diet re-evaluation;
    2. physical therapist, who will give physical activity course twice a week (1 h each);
    3. pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention.
  4. 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

Interventionel

Tilmelding (Faktiske)

182

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

    • Eiveniu str. 2
      • Kaunas, Eiveniu str. 2, Litauen, LT50009
        • Rasa Verkauskiene

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

10 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

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

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:
  • Metforal
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:
  • Metforal
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

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

Efterforskere

  • Studiestol: Rasa Verkauskiene, Professor, Lithuanian University of Health Sciences Hospital, Endocrinology Unit

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

1. maj 2013

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

30. juli 2012

Først indsendt, der opfyldte QC-kriterier

29. august 2012

Først opslået (Skøn)

3. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Study results are in progress with statistical analysis

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metformin

3
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