CTRI/2023/05/053003尚未招募不适用
SELECT-LIFE -SELECT follow-up study to evaluate Long-term Impact oF anti-obEsitymedication
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Novo Nordisk
- 入组人数
- 12,450
- 试验地点
- 15
- 主要终点
- Time to all-cause death
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
入排标准
- 年龄范围
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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- •Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.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.
结局指标
主要结局
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) | Approximately- 521 week
次要结局
- Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)Approximately- 521 week)
- Time to first occurrence of non-fatal myocardial infarction(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)Approximately- 521 week)
- Time to first occurrence of non-fatal stroke(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to diagnosis of type 2 diabetes(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to first occurrence of any type of cancer(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to first occurrence of a composite of obesity related cancer defined by WHO(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to first occurrence of knee replacement(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to first occurrence of bariatric surgery(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to first occurrence of anti-obesity medical treatment(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Time to first occurrence of use of continuous positive airways pressure (CPAP) device(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Total number of myocardial infarctions(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Total number of strokes(From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week)
- Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)(From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Approximately- 521 week)
- 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)(From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Approximately- 521 week)
- Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10)(From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Approximately- 521 week)
研究者
研究点 (15)
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