Characteristics of Young-onset Diabetes in Sub-Saharan Africa (YODA) Study (YODA)
Understanding the Characteristics of Young-onset Diabetes in Sub-Saharan Africa
研究概览
详细说明
The specific objectives will be to; (1) characterise a population with clinically diagnosed type 1 diabetes and to determine the proportion of islet autoantibody positivity rates and to compare with a similar cohort of patients in the UK, (2) to determine the proportion of participants with retained endogenous insulin secretion (C-peptide > 600pmol/l) and whether they have evidence of autoimmunity as assessed by islet autoantibody and the type 1 diabetes genetic risk score
Study setting: This study will be a multi-center cross-sectional study of clinically diagnosed type 1 diabetes patients who are currently on insulin treatment who are being followed-up in existing diabetes care centers in 4 sub-Saharan African countries; Cameroon, Uganda, Tanzania and South Africa. Recruitment will take place at regional diabetes care centers which usually serve as the main diabetes treatment hub for many smaller spoke clinics in the sub-region. In Cameroon, the Yaounde Central Hospital and the Bafoussam Regional Hospital will serve as main clinical sites. In Uganda the clinical sites involved are the Mulago National Referral and Teaching Hospital, St. Francis Hospital Nsambya, all in Kampala and the Masaka Regional Referral Hospital. The Muhimbili National Hospital in Dar Es Salaam will serve as the main clinical site in Tanzania. Cameroon, Uganda and Tanzania will carry out primary data collection over the study period while South Africa (University of Witwatersrand Medical School) will provide secondary data consisting of a minimal dataset and relevant collected samples for analysis. All these centers have existing diabetes care clinics with experienced staff who are used to collecting and providing data for research purposes.
Eligibility: All patients with a clinical diagnosis of type 1 diabetes or young-onset insulin treated diabetes, who were diagnosed before the age of 30 years will be eligible to be enrolled into the study. We estimated a minimum total sample size of 500 participants will have a high precision with 95% confidence intervals of 17-25% around a prevalence of 20% for a clinical or biological characteristics (e.g. retained C-peptide or presence of islet auto-antibodies) and 46-54% around a prevalence of 50%.
Sampling method: We will follow a systematic sampling method, enrolling consecutive eligible participants from the different primary collection clinical sites.
Enrollment: All consented patients will be interviewed using a structured pre-tested questionnaire (Data Collection Form) by a trained study staff to collect relevant information; demographic, socioeconomic, lifestyle, family history, history of diabetes and diabetes complications. The questionnaire used in this study is available in English and has been translated into the major local language(s); the appropriate questionnaire is used according to the participant's preference. After the interview, a short clinical examination will be performed to record anthropometric characteristics (weight, height, waist and hip circumferences) and blood pressure.
Using standardized operating procedures (SOPs), saliva, blood and urine samples will be collected from all study participants for biochemical analysis, and biobanking for future studies. Saliva will be used for DNA extraction and for the determination of type 1 genetic risk score (T1D GRS) using a 67 single nucleotide polymorphism score as described by Sharp et al. 2019. Venous whole blood will be used for full blood count and A1c determination. Plasma will be used for random C-peptide determination on the 801 module of the Cobas 8000 analyser and the measuring range will be truncated to <3pmol/L. Serum creatinine will be measured to assist in the interpretation of the C-peptide result. Islet autoantibodies, GAD, IA2 and ZnT8 will be measured in serum on the RSR Limited ELISA (RSR Limited, Cardiff, U.K.). Dipstick urinalysis will be done, with urinary C-peptide and creatinine measurement for the determination of the urinary C-peptide to creatinine ration (UCPCR). .
Data collected from the different clinical sites using the data collection form will be entered into a centralized data management tool (REDCap). All data will be anonymised before being stored in the data management system.
Ethical consideration: All participants will be required to provide a written informed consent before participating in the study. Refusal to participate will not affect the quality of care of the participants at the clinical sites. The study has received ethical clearance from the National Ethics Committee of Cameroon ( No 2018/12/1252/L/CNERSH/SP), and the Uganda Virus Research Institute (GC/127/19/12/736), Muhimbili National Hospital (MNH/IRB/I/2020/019) and Human Research Ethics Committe, South Africa (M200174).
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Eugene Sobngwi, MD, PhD
- 电话号码:+237 675088750
- 邮箱:sobngwieugene@yahoo.fr
研究联系人备份
- 姓名:Jean-Claude Katte, MD, MSc
- 电话号码:+237 677587929
- 邮箱:jckatte@gmail.com
学习地点
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Entebbe、乌干达、P.O. Box 49
- 招聘中
- Uganda Virus Research Institute
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接触:
- Moffat Nyirenda, PhD
- 邮箱:Moffat.Nyirenda@lshtm.ac.uk
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Gauteng
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Johannesburg、Gauteng、南非
- 主动,不招人
- School of Pathology, University of Witwatersrand
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Centre
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Yaounde、Centre、喀麦隆
- 招聘中
- National Obesity Centre, Yaounde Central Hospital
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接触:
- Eugene Sobngwi
- 邮箱:sobngwieugene@yahoo.fr
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Dar Es Salaam、坦桑尼亚
- 招聘中
- Muhimbili National Hospital
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接触:
- Edna Majaliwa
- 邮箱:ednasiima07@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes at age less than 30 years
- Currently use insulin as a permanent treatment
- Able to consent to study
Exclusion Criteria:
- Refusal to provide written informed consent
学习计划
研究是如何设计的?
设计细节
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 |
---|---|---|
Proportion of retained endogenous insulin secretion
大体时间:Baseline
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Random non-fasting C-peptide level
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Baseline
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Islet auto-antibody titre and positivity proportions
大体时间:Baseline
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GADA, IA-2A, ZnT8A
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Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Type 1 diabetes genetic risk score
大体时间:Baseline
|
Proportion with T1D GRS > 50th centile
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Baseline
|
合作者和调查者
调查人员
- 首席研究员:Eugene Sobgnwi, MD, PhD、University of Yaounde 1/ Yaounde Central Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
与本研究相关的术语
其他研究编号
- CNO012021
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
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