跳至主要内容
临床试验/ACTRN12620000650998
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

发起方
Aotearoa Clinical Trials

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