SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,439
- 试验地点
- 54
- 主要终点
- Time to diagnosis of type 2 diabetes
研究概览
简要总结
Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial.
SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends.
SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking.
When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study.
Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor.
The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
- •Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
排除标准
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Questionnaire survey
Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
干预措施: No treatment given (Other)
结局指标
主要结局
Time to diagnosis of type 2 diabetes
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of anti-obesity medical treatment
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of knee replacement
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of use of continuous positive airways pressure (CPAP) device
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of non-fatal myocardial infarction
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of non-fatal stroke
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of any type of cancer
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Change in Patient reported quality of life questionnaire (EQ-5D-5L) from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
时间窗: From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
EQ-5D-5L score The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale \[VAS\]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.
Time to all-cause death
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Total number of myocardial infarctions
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10)
时间窗: From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Days
Time to first occurrence of bariatric surgery
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
时间窗: From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Measured in Kg
Time to first occurrence of a composite of obesity related cancer defined by WHO
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
Total number of strokes
时间窗: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Measured in months
次要结局
未报告次要终点