ACTRN12620000650998进行中(未招募)未知
A pilot study to evaluate the benefit of intensive lifestyle intervention (low calorie diet and exercise) with or without bariatric (weight-reduction) surgery in high-risk adolescents with morbid obesity.
Aotearoa Clinical Trials0 个研究点目标入组 20 人开始时间: 2020年6月5日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 189 Months 至 18 Years(—)
- 性别
- All
入选标准
- •1.Be aged between 15 years 9 months and 18 years inclusive
- •2.Have been diagnosed with morbid obesity defined as a body mass index (BMI) >35 kg/m2 at the baseline visit.
- •3.Have pre-diabetes or type 2 diabetes mellitus as confirmed by oral glucose tolerance test at the baseline visit.
- •4.Provide written informed consent to participate in the study
排除标准
- •1.History of type 1 diabetes defined as age of onset <20 years and/or history of continuous treatment with insulin since diagnosis and/or positive antibodies to glutamic acid decarboxylase [GAD] or islet tyrosine phosphatase 2 [IA2] at baseline.
- •2.History of drug or alcohol abuse
- •3.Pregnancy
- •4.Serious co-morbid conditions that are likely to affect survival
- •5.Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.
研究者
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