ACTRN12621001348842尚未招募未知
The effect of cognitive-behavioral therapy-based intervention on HbA1c of Type II diabetes patients with comorbid metabolic syndrome—a randomised controlled trial
Grifftih University0 个研究点目标入组 280 人开始时间: 2021年10月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Key inclusion criteria:
- •(1) The participants will be recruited from the Endocrinology Department of Ningbo First Hospital, Ningbo city, Zhejiang province, China. Recruited participants will be included in this research if they meet the following criteria:
- •1) Diagnosed type 2 diabetes (T2DM) with comorbid metabolic syndrome (MS);
- •2) Age 18-75 years old;
- •3) Currently does not participate in similar intervention programs;
- •4) Sign an informed consent form, willing to participate in this study, and have good compliance.
- •(2) The specific diagnostic criteria for diabetes refer to the report of the WHO Diabetes Expert Committee, 1999, which is as follows: typical symptoms of diabetes plus
- •1) random blood glucose greater than or equal to 11.1 mmol/L;
- •2) fasting blood glucose greater than or equal to 7.0 mmol/L;
- •3) oral glucose tolerance test 2 hours greater than or equal to 11.1 mmol/L;
- •4) When there is no definite hyperglycemia, it should be confirmed by repeated tests.
- •(3) The specific diagnostic criteria for metabolic syndrome refers to the IDF standard (Alberti et al., 2005; Collaborators):
- •central obesity, WC greater than or equal to 90cm (Chinese male) or greater than or equal to 80cm (Chinese female), and those who have 2 or more of the following components,
- •1) TG greater than or equal to 1.70mmol/L or have received relevant treatment;
- •2) HDL-C less than 1.03mmol/L (male) or less than 1.30mmol/L (female), or have received relevant treatment;
- •3) SBP greater than or equal to 130 or DBP greater than or equal to 85mmHg, or have received relevant treatment;
- •4) FPG greater than or equal to 5.6mmol/L or have been diagnosed with T2DM.
排除标准
- •Participants will be excluded from the study if 1) T1DM; 2) they are pregnant; 3) taking medications unrelated to T2DM or MS; 4) had advanced diabetes complications; 5) had a severe mental illness, is not able to answer questions and participate in intervention activities; 6) cannot use the mobile phone.
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