ISRCTN11459997进行中（未招募）未知
Dapagliflozin, Exercise Training and physicAl function: the DETA trial
niversity of Leicester0 个研究点目标入组 135 人开始时间: 2020年9月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 30/08/2023:
- •1. Age 40 to 75 years, inclusive
- •2. Diagnosed T2DM, treated by lifestyle management alone or in combination with mono- or
- •combination therapy with oral glucose-lowering pharmacological therapies (with exception of
- •pre-defined exclusion criteria)
- •3. HbA1c =10.5% (<91 mmol/mol)
- •4. Historical evidence of functional limitation or frailty defined as at least one of :
- •4.1. Impaired physical function or frailty; SPPB score 1 to 10 (inclusive) recorded within the
- •preceding 5 years
- •4.2. A coding of mild-to-moderate frailty based on the Electronic Frailty Index (eFI) within
- •primary care
- •4.3. V02peak recorded within the preceding 5 years
- •4.3.1. Men <50 years: <30 mL/kg, Men 50+ years: <25 mL/kg
- •4.3.2. Women <50 years: <25 mL/kg, Women 50+ years: <22 mL/kg
- •4.4. SARC-F questionnaire score of 4 or more
- •4.5. BMI =25 kg/m² (= 22.5 kg/m² if of South Asian ethnicity)
- •4.6. Weight stable; <3 kg weight change in the preceding 3 months
- •4.7. Treatment stable; no significant change to glucose-lowering regimen in the preceding 3
- •months, as determined by a study investigator
- •4.8. Able and willing to give informed consent
- •4.9. Able to understand spoken English
- •4.10. Able to take part in structured exercise training (in the opinion of the Investigator)
- •Previous inclusion criteria:
- •1. Age 40 to 75 years, inclusive
- •2. Diagnosed T2DM, treated by lifestyle management alone or in combination with mono- or combination therapy with oral glucose-lowering pharmacological therapies (with exception of pre-defined exclusion criteria)
- •3. HbA1c 6.5 to 10% (47 to 86 mmol/mol), inclusive
- •4. Historical evidence of functional limitation or frailty defined as at least one of :
- •4.1. Impaired physical function or frailty; SPPB score 1 to 10 (inclusive) recorded within the preceding 5 years
- •4.2. A coding of mild-to-moderate frailty based on the Electronic Frailty Index (eFI) within primary care
- •4.3. V02peak =18 ml/kg recorded within the preceding 5 years
- •4.4. SARC-F questionnaire score of 4 or more
- •4.5. BMI =25 kg/m² (= 22.5 kg/m² if of South Asian ethnicity)
- •4.6.Weight stable; <3 kg weight change in the preceding 3 months
- •4.7. Treatment stable; no significant change to glucose-lowering regimen in the preceding 3 months, as determined by a study investigator
- •4.8. Able and willing to give informed consent
- •4.9. Able to understand spoken English
- •4.10. Able to take part in structured exercise training (in the opinion of the Investigator)
排除标准
- •1.Individuals with type 1, gestational or monogenic diabetes mellitus
- •2. eGFR <60 ml/min per 173m² or as per licencing at the point of prescription
- •3. Individuals with familial renal glycosuria
- •4. Documented or self-reported cirrhosis
- •5. Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •6. Individual with recurrent balanitis, vaginal or urinary tract infections
- •7. Current or planned pregnancy, or breast feeding
- •8. Females of childbearing age, unwilling to use adequate contraceptive methods during the study period
- •9. Currently on SLGT2i, GLP-1RA, basal-bolus or premixed insulin therapies
- •10. Contra-indications to exercise or SGLT2i therapy
- •11. Current participation in another research study with investigational medical product
- •12. Scoring 0 on the SPPB, or otherwise unable to complete the test due to severe functional limitations
- •13. Active malignancy; at discretion of study clinician
- •14. Serious illness with life-expectancy < 1 year or other significant illness which, in the opinion of a study clinician, precludes involvement
- •15. Individuals with history of chronic pancreatitis
- •16. Individuals with Latent Autoimmune Diabetes in Adults (LADA)
- •17. Patients with a history of excessive alcohol consumption
- •18. Patients on a severely calorie restricted diet (i.e. <800 calories per day)
- •Additional exclusion criteria for MRI scanning visits (this does not impact on the participant’s enrolment in the study):
- •19. Individuals with absolute contra-indication to MRI that, in the opinion of a study clinician, precludes an MRI scan will not be invited to attend the MRI visits, but will engage in all other aspects of the study.
- •Additional exclusion criteria for individuals wishing to undertake skeletal muscle biopsy sub-study (this does not impact on the participant’s enrolment in the main study):
- •20. Individuals taking any medication that, in the opinion of a study clinician, preclude involvement in the muscle biopsy sub-study (including blood thinning medications)
- •21. Individuals with any concurrent disease/condition that, in the opinion of a study clinician, precludes involvement in the muscle biopsy sub-study (including those with low platelet counts and those with blood borne infections)
- •22. Individuals with a documented or self-reported history of local anaesthetic sensitivity
研究者
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