Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Peripheral Neuropathy assesed by Pinprick
研究概览
简要总结
The overall objective of this project is to describe the prevalence of and risk factors to diabetic neuropathy in a representative cohort of diabetes patients and to investigate pathophysiological conditions in those patients with neuropathy.
This project will yield substantial new knowledge about the prevalence of diabetic neuropathy in type 1 and type 2 DM persons, new risk factors to neuropathy and the association to other diabetic complications. Findings related to the study may facilitate new treatment regimens prompting a better neuropathy treatment with reduced incidence of diabetic complications.
First patients at SDCC will be screened for diabetic neuropathy (Study 1.1) with an extended neuropathy screening program as an addition to the routine neuropathy screening at SDCC. 1000 patients with type 1 DM and 1000 patients with type 2 DM will be included.
This screening study is a prerequisite for the further study of study participants in substudies investigating associations between diabetic neuropathy and diabetic complications as described below.
Hypothesis:
Several patients with diabetes have undiagnosed neuropathy and associated diabetic complications. We hypothesize that diabetic neuropathy is underdiagnosed at SDCC and can be diagnosed with targeted screening with new and traditional measuring techniques. In addition, several patients may have complications related to neuropathy, including foot complications, and dysregulation of glucose metabolism
Aim:
This study consists of a screening study (study 1.1) and two substudies (1.2 and 1.3 ). Study 1.1 is a cross-sectional study describing the prevalence of diabetic neuropathy based on questionnaire data and objective measures as described below and associated diabetic complications including foot complications.
The primary aim is to explore the prevalence of diabatic neuropathy in patients with type 1 and type 2 DM at SDCC and secondarily to explore associations between diabetic neuropathy and complications, as described in the respective sections below.
The substudy 1.2 is an observational single center cohort study with the aim of investigating associations between neuropathy diagnosed with new devices for measurement of neuropathy and foot complications in patients with type 1 and type 2 diabetes.
The substudy 1.3 is an observational single center cohort study investigating the association between CAN and glycemic variability in patients with type 1 diabetes.
详细描述
Study 1.1 Diabetic Neuropathy Screening Study Objective The objective of this study is to investigate the prevalence of diabetic neuropathy at the outpatient clinic of SDCC and to investigate the association between diabetic neuropathy and diabetic complications.
Aims Primary aims
- To describe the prevalence of the following kinds of diabetic neuropathy in a representative subset of type 1 and type 2 DM persons at SDCC:
- peripheral neuropathy assessed by traditional screening tools
- peripheral neuropathy assessed by novel screening tools
- autonomic neuropathy assessed by novel point-of-care screening tools
- peripheral and autonomic neuropathy assessed by validated neuropathy questionnaires
Secondary aims
- To explore the association between:
- the above-mentioned forms of neuropathy and possible risk factors for neuropathy such as HbA1c, urine albumin-creatinine-ratio, incidences of severe hypoglycaemia and ketoacidosis, BMI, vitamin B12, levels of SpO2 and quantitative measures of diabetic neuropathy
- the above-mentioned forms of neuropathy questionnaire data on mental health and wellbeing
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Peripheral Neuropathy assesed by Pinprick
时间窗: 18.10.2019-31.12.2022
Neuropathy assesed by Pinprick: Pain Sensation with a 40g needle
Autonomic Neuropathy assesed by Sudoscan
时间窗: 18.10.2019-31.12.2022
Neuropathy assesed by Sudoscan: Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet
Peripheral Neuropathy assesed by Biothesiometer
时间窗: 18.10.2019-31.12.2022
Neuropathy assesed by Biothesiometer: Peripheral vibration sensation (volt)
Peripheral Neuropathy assesed by Monofilament
时间窗: 18.10.2019-31.12.2022
Neuropathy assesed by Monofilament Light touch with 10 and 75 g monofilament
Peripheral Neuropathy assesed by DPN-check
时间窗: 18.10.2019-31.12.2022
Neuropathy assesed by DPN-check: Sural Nerve conduction velocity(m/s) of the Sural nerves by DPN-check.
Peripheral Neuropathy assesed by Roll-temp
时间窗: 18.10.2019-31.12.2022
Neuropathy assesed by Roll-temp: Cold and warm sense of foot and lower leg by
Cardivascular Autonomic Neuropathy assesed by Vagus
时间窗: 18.10.2019-31.12.2022
The examination consists of 4 measures, all aimed at measuring heart rate. Measurements are taken for 5 minutes rest, change of position from lying to standing position, during deep breathing and by Valsalva (by breathing in a mouthpiece with a 40 mmHg resistance).
次要结局
- Pressure pain sensitivity(18.10.2019-31.12.2022)
- Peripheral Neuropathy assesed by DPN-check(18.10.2019-31.12.2022)
- Autonomic Neuropathy assesed by Sudoscan(18.10.2019-31.12.2022)
- Oxygen Saturation in supine and standing position(18.10.2019-31.12.2022)
- Blood pressure in supine and standing position(18.10.2019-31.12.2022)