Obesity in Children and Adolescents: Associated Risks and Early Intervention

NCT01677923 | Completed Phase 3 DMC

• 1 other identifier: BE-2-1
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

weight; body mass index; lipid profile; glucose profile

Outcome Measures

Primary Outcomes (1)

• Body mass index changes

  decrease in body mass index

  12 months

Secondary Outcomes (5)

• Glucose homeostasis

  12 month

• Lipid profile

  12 months

• Metabolic syndrome

  12 months

• Hepatosteatosis

  12 months

• Polycystic ovary syndrome (PCOS) and hyperandrogenism in females

  12 months

Other Outcomes (1)

• safety

  12 months

Study Arms (4)

Control without Metformin

NO INTERVENTION

Conventional management of obesity including basic instructions on diet and physical activity

Control with Metformin

EXPERIMENTAL

Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment

Drug: Metformin

Intervention with Metformin

EXPERIMENTAL

Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment.

Drug: Metformin

Intervention without Metformin

NO INTERVENTION

Intensive physical activity course twice per week and monthly diet control by dietitian

Interventions

Metformin DRUG

Metformin 500 mg BID for 12 months

Also known as: Metforal

Control with Metformin; Intervention with Metformin

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Rasa Verkauskiene

Kaunas, Eiveniu Str. 2, LT50009, Lithuania

Location

MeSH Terms

Conditions

Obesity; Body Weight

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Rasa Verkauskiene, Professor

  Lithuanian University of Health Sciences Hospital, Endocrinology Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Department and Institute of Endocrinology, Lithuanian UHS

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: September 3, 2012
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

LI (1)