ISRCTN88646091进行中（未招募）4 期
Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular dysfunction (DIASTOLIC)
niversity of Leicester0 个研究点目标入组 120 人开始时间: 2015年11月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
- 2018 preliminary study in: https://www.ncbi.nlm.nih.gov/pubmed/29661781 (added 10/04/2019) 2. 2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30928925 (added 10/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Diabetic patient inclusion criteria:
- •1. Aged between 18 and 60 years
- •2. Capacity to provide informed consent before any trial related activities
- •3. Established T2DM for at least 3 months
- •4. HbA1c = 9% if on triple therapy or = 10% on diet & exercise or monotherapy or dual therapy
- •5. Current glucose lowering therapy either mono, dual or triple of any combination of metformin, sulphonylurea, DPPIV inhibitor, GLP1 therapy or an SGLT2 +/- diet and exercise
- •6. Body mass index > 30Kg/m2 (white Europeans) or > 27Kg/m2 (South East Asian or Afro-Caribbean)
- •7. Diagnosis of T2DM before the age of 50 years of age
- •Healthy controls inclusion criteria:
- •1. Aged between 18 and 60 years
- •2. Capacity to provide informed consent before any trial related activities
- •3. Body mass index < 30Kg/m2 (white Europeans) or < 27Kg/m2 (South East Asian or Afro-Caribbean)
- •4. No cardiovascular symptoms (angina, limiting dyspnoea)
排除标准
- •Diabetic patient exclusion criteria:
- •1. Aged under 18 or over 60
- •2. HbA1c >10%
- •3. Diabetes duration >12 years
- •4. Currently taking more than three glucose lowering therapies
- •5. Weight-loss of >5kg in the preceding 6 months
- •6. Stage 4 or 5 chronic kidney disease (eGFR <30ml/min/1.73m2)
- •7. Current therapy with insulin, thiazolidinediones (or within the preceeding three months), steroids or atypical antipsychotic medication, untreated thyroid disease
- •8. Known ischaemic heart disease or heart failure
- •9. Inability to exercise or undertake a TDR
- •10. Absolute contraindication to CMR
- •11. Cardiovascular symptoms (angina, limiting dyspnoea).
- •12. Patients with asthma will be assessed for suitability of adenosine stress. If adenosine is contraindicated (severe asthma) subjects can participate without perfusion assessment
- •13. Inflammatory condition e.g. connective tissue disorder, rhematoid arthritis.
- •Healthy controls inclusion criteria:
- •1. Aged under 18 or over 60
- •2. Diabetes or impaired glucose tolerance
- •3. Obesity (BMI >30 (white european) or >27 (Asian or Afro-Caribbean)
- •4. Severe asthma
- •5. History of hypertension, or blood pressure in excess of either 160mmHG systolic or 100mmHG diastolic and currently untreated
- •6. Inflammatory condition e.g. connective tissue disorder, rheumatoid arthritis
- •7. Congenital heart disease
- •8. Renal impairment (eGFR <60ml/min/m2)
- •9. Other conditions that in the opinion of the investigators may limit exercise capacity or be associated with subclinical cardiac dysfunction
- •10. Competitive athletes
研究者
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