Time to Complications Occurs in Diabetes. Risk Factors Determine When Diabetes Complications Occur
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Time to autonomous neuropathic ulcers and Amputation
研究概览
简要总结
Diabetes causing serious complications is well known. In this study the aim is to follow 950 patients with diabetes for 15 years to study when, in who and how the diabetes complications occurs.
详细描述
Background:
That diabetes cause serious diabetic complications from the eyes, kidneys, nerves and large vessels is known. Good metabolic control during the first 8-10 years has been shown to delay and even alleviate diabetes complications, but not entirely prevent them. When complications occur early after diabetes onset there are also likely genetic causes. If the various diabetes complications have different formation mechanisms or different sensitivity of blood sugar impact is not studied previously.
Hypothesis:
- Genetic factors determine increased risk of early onset of complications.
- Oxidative stress increases the risk of complications.
- Inflammation, hyperlipidemia and hypertension leads to hypoxia and oxidative stress.
- Combined hypoxia and hyperglycemia leads to complications.
Questionnaires:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 1, 2 or LADA: 18-75 years of age.
- •Group A: 150 Type 1 Diabetes, duration 15 years (+/-2 years) and 150 Type 2
- •Diabetes 2 years (+/-2 years) (50% F/M)
- •Group B: 150 Type 1 Diabetes, duration 20 years (+/-2 years) and 150 Type 2
- •Diabetes 7 years (+/-2 years) (50% F/M)
- •Group C: 150 Type 1 Diabetes, duration 25 years (+/-2 years) and 150 Type 2
- •Diabetes 12 years (+/-2 years) (50% F/M)
- •Group D: 50 LADA, onset after 35 years of age, duration of 5-10 years (50% F/M)
- •Type 1 Diabetes: Positive ICA antibodies and/or GAD-antibodies and/or neg C-peptide. Debut <30 years of age.
- •Type 2 Diabetes: Negative ICA-antibodies and GAD-antibodies and pos C-peptide (>0.35 mmol/l).
- •LADA: Positive ICA-antibodies and/or GAD-antibodies. Debut >35 years of age.
排除标准
- 未提供
结局指标
主要结局
Time to autonomous neuropathic ulcers and Amputation
时间窗: 0, 3-5, 8-10 and 13-15 years
Time to nephropathy
时间窗: 0, 3-5, 8-10 and 13-15 years
Time to peripheral neuropathy
时间窗: 0, 3-5, 8-10 and 13-15 years
Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation
时间窗: 0, 3-5, 8-10 and 13-15 years
Time to retinopathy
时间窗: 0, 3-5, 8-10 and 13-15 years
次要结局
- Inflammatory markers(0, 3-5, 8-10 and 13-15 years)
- Weight(0, 3-5, 8-10 and 13-15 years)
- Q10(0, 3-5, 8-10 and 13-15 years)
- CRP(0, 3-5, 8-10 and 13-15 years)
- Seated blood pressure(0, 3-5, 8-10 and 13-15 years)
- IGFBP-1(0, 3-5, 8-10 and 13-15 years)
- Pulse(0, 3-5, 8-10 and 13-15 years)
- DNA(0, 3-5, 8-10 and 13-15 years)
- Endothelial markers(0, 3-5, 8-10 and 13-15 years)
- Blood lipids(0, 3-5, 8-10 and 13-15 years)
- Oxidative stress(0, 3-5, 8-10 and 13-15 years)
- IGF-1(0, 3-5, 8-10 and 13-15 years)
- BMI(0, 3-5, 8-10 and 13-15 years)
- Waistlines(0, 3-5, 8-10 and 13-15 years)