Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Body mass index changes
研究概览
简要总结
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.
详细描述
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.
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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.
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nd group - intensive diet and physical activity group: Children will be seen
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by a dietician once a month for diet re-evaluation;
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physical therapist, who will give physical activity course twice a week (1 h each).
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pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention.
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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
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a dietician once a month for diet re-evaluation;
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physical therapist, who will give physical activity course twice a week (1 h each);
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pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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;
研究组 & 干预措施
Control with Metformin
Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment
干预措施: Metformin (Drug)
Intervention with Metformin
Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment.
干预措施: Metformin (Drug)
结局指标
主要结局
Body mass index changes
时间窗: 12 months
decrease in body mass index
次要结局
- Glucose homeostasis(12 month)
- Lipid profile(12 months)
- Hepatosteatosis(12 months)
- Metabolic syndrome(12 months)
- Polycystic ovary syndrome (PCOS) and hyperandrogenism in females(12 months)
研究者
Rasa Verkauskiene
Professor, Head of Department and Institute of Endocrinology, Lithuanian UHS
Lithuanian University of Health Sciences