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Clinical Trials/EUCTR2011-006352-36-LT
EUCTR2011-006352-36-LT
Active, not recruiting
Phase 1

Obesity in children and adolescents: complications, associated risks and early intervention (lifestyle changes and insulin sensitivity improving medicine (metformin) effectiveness and safety evaluation) - OCA

ithuanian University of Health Sciences, Endocrinology Department0 sites100 target enrollmentJanuary 14, 2013
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DrugsMetforal 500 mg / tablet

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ithuanian University of Health Sciences, Endocrinology Department
Enrollment
100
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 14, 2013
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ithuanian University of Health Sciences, Endocrinology Department

Eligibility Criteria

Inclusion Criteria

  • •Age 10\-17 yrs;
  • •BMI \> 85th percentile for age and gender (by IOTF);
  • •Living in Kaunas and its region;
  • •No obvious chronic diseases;
  • •Not on long\-term steroid oral / IV treatment;
  • •Childbearing age ladies using contraception;
  • •Informed consent of the patient and parents (official caregivers);
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •F.1\.2 Adults (18\-64 years) no

Exclusion Criteria

  • •Age less than 10 or above 17 yrs;
  • •Diagnosis of type 1 diabetes;
  • •Chronic illness that may affect physical activity, hormone and metabolic profile;
  • •Insulin treatment;
  • •Steroid treatment;
  • •Planning to move from Kaunas or its region in the period of 1 year;
  • •Childbearing age ladies non\- using contraception, pregnancy planning;
  • •Protocol refused by the patient or his parents;

Outcomes

Primary Outcomes

Not specified

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