Benefits of Retained Insulin for Good Health (BRIGHT)
Understanding the Impact of Endogenous Insulin Secretion on Clinical Outcomes in Type 1 Diabetes and the Optimal Approach to C-peptide Measurement for Outcome Prediction
The purpose of this research is to understand the impact of retained endogenous insulin (as measured by C-peptide) on quality of life and related outcomes in people living with insulin treated diabetes, and, in those living with type 1 diabetes, to determine the pragmatic and non-pragmatic C-peptide measures which have the strongest association with clinical benefit (including repeated home samples and derived measures of beta cell function). The investigators will do this in two ways:
Firstly, the investigators will extend a large existing prospective study of new adult onset diabetes (Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes (StartRight)) https://clinicaltrials.gov/ct2/show/NCT03737799) which has followed 1800 participants for median 4 years from diabetes diagnosis. Participants with insulin treated diabetes will be invited to take part in a further research visit remotely or face to face. The investigators will assess the longitudinal relationship between C-peptide and the available quality of life, mental health status and healthcare utilisation measures over up to 9 years from diabetes diagnosis and assess additional measures in cross sectional analysis.
In the second part of this research, the investigators will utilise cohorts of over 2500 participants with type 1 diabetes, measured C-peptide and consent to recontact to recruit 200 participants with a range of C-peptide. Eligible participants with C-peptide measured in clinical care may also be invited to take part. The investigators will undertake detailed assessment of complex and pragmatic measures of C-peptide and beta cell function and compare performance in predicting glycaemic outcomes (using data from continuous glucose monitors) and (where relevant) patient reported outcomes.
研究概览
详细说明
The purpose of this study is to understand the possible benefits of restoring insulin secretion in people living with diabetes, and to understand how insulin secretion can be best measured in people living with diabetes.
Most people living with type 1 diabetes stop making their own insulin, this means that insulin injections are needed to survive. It also means their blood glucose is variable, meaning it is very difficult to control blood glucose levels. This is in contrast to type 2 diabetes, where most people keep making their own insulin, and loss of insulin production is uncommon.
Previous research has shown that some people with type 1 diabetes keep making some of their own insulin, and this can be very helpful for their blood glucose control. However, there is limited information on long term benefits of making insulin, and other possible benefits, such as on wellbeing, have not been studied. It is important that the full benefits of making insulin are known as new treatments have been developed to preserve insulin secretion in type 1 diabetes, and/or to restore insulin secretion. These treatments are expensive and can have side effects, and have been studied only in small studies for a short amount of time. It is important to fully understand the likely long-term benefits of preserving or restoring insulin secretion to know whether healthcare providers like the NHS should fund these treatments.
At present research studies that are testing new treatments to preserve or restore a person's insulin production need to frequently test insulin secretion, using a test called a mixed meal tolerance test that needs to be undertaken in a hospital setting and takes at least 2.5 hours. This makes these studies difficult to take part in, and expensive to run. Insulin production can now be measured at home, on a finger-prick test, but more information is needed on the best way to do the home test for these kinds of studies.
This research has two parts. In the first part of this research the investigators will measure insulin secretion (using a test called C-peptide) in 500 people with insulin treated diabetes who have already taken part in a large recent study that measured their insulin secretion, and other important measures such as their quality of life and use of healthcare services, every year for up to 4 years after diabetes diagnosis. There will be assessment of participants' quality of life and other measures related to diabetes. The investigators will use this information, and the information already collected in the study, to understand the effects of retaining or loosing insulin production over up to 9 years from diabetes diagnosis, and compare whether this differs in type 1 and 2 diabetes.
In the second part of this research the investigators will recruit 200 participants with type 1 diabetes who have had their insulin secretion measured in part one of this research, in other research or in clinical care. Information from this previous testing will be used to ensure participants are recruited with a range of insulin production. Participants will attend a research facility for assessment of their insulin production over 2 hours after a liquid meal similar to a milkshake. Participants will then undertake this test at home, using finger-prick samples after the same liquid meal, and after 3 of their own normal meals. Participants will also monitor their glucose over 2 weeks using a device called a continuous glucose monitor. This information will be used to understand if home measures are as accurate as the test in the research facility, and work as well in predicting a person's risk of low glucose (hypoglycaemia) and how variable their glucose is.
The end result of this research will be important information to inform the design of studies of new treatments to preserve or restore insulin secretion for people living with diabetes and understand the likely long-term benefits of these treatments.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：BRIGHT Study Research Team
- 电话号码：+44 1392408181
- 邮箱：rduh.brightstudy@nhs.net
学习地点
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Bath、英国、BA1 3NG
- 招聘中
- D1 Wolfson Centre Research and Development
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接触：
- Diabetes and Lipids Research Team (Bath)
- 电话号码：+44 1225821304
- 邮箱：ruh-tr.DiabetesAndLipidsResearch@nhs.net
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首席研究员：
- Rachel Mathias
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Bristol、英国、BS10 5NB
- 招聘中
- Clinical Research Centre
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首席研究员：
- Georgina Russell
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接触：
- Diabetes Research Team (Bristol)
- 电话号码：+44 1174148125
- 邮箱：nbn-tr.nbtdiabetesresearch@nhs.net
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Cornwall
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Truro、Cornwall、英国、TR1 3LJ
- 招聘中
- Diabetes and Endocrine Centre
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首席研究员：
- Duncan Browne
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接触：
- Diabetes and Renal Research Team (Truro)
- 电话号码：+44 1872254655
- 邮箱：rcht.diabetesresearch@nhs.net
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Devon
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Exeter、Devon、英国、EX2 5DW
- 招聘中
- NIHR Exeter Clinical Research Facility
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接触：
- BRIGHT Study Research Team
- 电话号码：+44 1392408181
- 邮箱：rduh.brightstudy@nhs.net
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首席研究员：
- Angus Jones
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
ARM 1: Participants who have previously taken part in the StartRight study (NCT03737799) with consent to re-contact for future research (from sites across the United Kingdom (UK)).
ARM 2: Participants who have previously taken part in the StartRight study or other diabetes research cohorts, as well as patients referred by their clinician or self-referred (across the UK).
描述
ARM 1
Inclusion Criteria:
- Previously recruited to the StartRight study (NCT03737799) with consent to be contacted for further research
- Clinical diagnosis of diabetes & Insulin treated
- Able and willing to provide informed consent/assent.
- Aged 18 years or older.
ARM 2
Inclusion Criteria:
- Clinical diagnosis of Type 1 diabetes
- Known C-peptide, measured as part of previous research or as part of diabetes clinical care OR Where C-peptide is not measured, participant must be within 7 years of diagnosis and have at least 1 positive islet antibody, measured at any time since diabetes diagnosis.
- Where measured C-peptide is >600pmol/L, previous positive islet autoantibodies.
- Able and willing to provide informed consent
- Aged 18 years or older
Exclusion Criteria:
- Renal failure defined by eGFR <30mL/min/1.73 m²
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Arm 1
Adults (aged >= 18 years) diagnosed with diabetes for >3 years, treatment with insulin, and previously taken part in the StartRight study with consent to re-contact.
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观察性的
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Arm 2
Adults (aged >= 18 years) diagnosed with type 1 diabetes.
Known level of insulin secretion, measured using a C-peptide test after diabetes diagnosis.
Participants will have had C-peptide measured as part of a previous research study or as part of their diabetes clinical care.
Where C-peptide is not measured, participant must be within 7 years of diagnosis and have at least 1 positive islet antibody, measured at any time since diabetes diagnosis.
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观察性的
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Capillary C-peptide measured 1-5 hours after a meal containing carbohydrates (Arm 1)
大体时间：1 day during study participation
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Analysis of Arm 1 will assess the relationship between home post-meal C-peptide (measured serially from within 12 months of diagnosis up to 10 years post-diagnosis, through extension of an existing study), and the secondary outcomes listed below.
This will be assessed as longitudinal change over time (Arm 1 cohort) and cross-sectionally using the most recent visit data from the combined Arm 1 and Arm 2 cohorts.
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1 day during study participation
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Plasma and capillary C-peptide (Arm 2)
大体时间：90-minutes post baseline
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Primary analysis for Arm 2 will assess the relationship between home capillary C-peptide measurements (post-meal, assessed individually & as the average of up to three measurements, and 90-minute post-mixed meal tolerance test) and 90-minute plasma C-peptide measured during a mixed meal tolerance test conducted at a research centre.
Secondary analysis will compare the relationship between C-peptide measures and the continuous glucose monitoring secondary outcome listed below.
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90-minutes post baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Questionnaire assessed hypoglycaemia and hypoglycaemia unawareness (Arm 1 & Arm 2)
大体时间：Symptoms experienced during 4 weeks prior to study enrolment
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Results from analysis of data from Modified Clarke/Edinburgh Hypoglycaemia History questionnaire
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Symptoms experienced during 4 weeks prior to study enrolment
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Questionnaire assessed emotional burden (Arm 1 & Arm 2)
大体时间：Symptoms experienced during 4 weeks prior to study enrolment
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Results from analysis of data from Diabetes Distress Scale questionnaire
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Symptoms experienced during 4 weeks prior to study enrolment
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Questionnaire assessed quality of life/wellbeing (Arm 1 & Arm 2)
大体时间：Symptoms experienced during 4 weeks prior to study enrolment
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Results from analysis of data from Veterans RAND 12-Item Health Survey (VR-12) questionnaire
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Symptoms experienced during 4 weeks prior to study enrolment
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Changes/updates to diabetes treatment, complications and healthcare utilisation for relevant medical conditions since previous study visit (Arm 1)
大体时间：Up to 3 years prior to study enrolment
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Data collected during current study visit combined with data from previous study visit.
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Up to 3 years prior to study enrolment
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Continuous glucose monitor measured glucose variability and hypoglycaemia (Arm 2)
大体时间：14 days during study participation
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Analysis for Arm 2 will compare the relationship of different C-peptide measures to glucose variability (assessed as Standard Deviation glucose) and hypoglycaemia (assessed as % time glucose below 3mmol/L), derived from 14 days of continuous interstitial glucose monitoring
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14 days during study participation
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.