EUCTR2019-004586-41-GB进行中（未招募）1 期
Impact of exercise training in combination with dapagliflozin on physical function in adults with type 2 diabetes mellitus: A Randomised controlled trial - Dapagliflozin, Exercise Training and physicAl function; the DETA trial
niversity of Leicester0 个研究点目标入组 140 人开始时间: 2020年8月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(i)Men and women
- •(ii)Age 40 to 75 years, inclusive
- •(iii)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; see below)
- •(iv)HbA1c 6.5 to 10% (47 to 86 mmol/mol), inclusive
- •(v) Historical evidence of functional limitation or frailty defined as at least one of :
- •a.Impaired physical function or frailty; SPPB score 1 to 10 (inclusive) recorded within the preceding 5 years
- •b.A coding of mild-to-moderate frailty based on the Electronic Frailty Index (eFI) within primary care
- •c.V02peak = 18 ml/kg recorded within the preceding 5 years
- •d. SARC-F questionnaire score of 4 or more
- •(vi)BMI = 25 kg/m2 (= 22.5 kg/m2 if of Ssouth Asian ethnicity)
- •(vii)Weight stable; < 3kg weight change in preceding 3 months
- •(viii)Treatment stable; no significant change to glucose-lowering regimen in the preceding 3 months, as determined by a study investigator
- •(ix)Able and willing to give informed consent
- •(x)Able to understand spoken English
- •(xi)Able to take part in structured exercise training (in the opinion of the Investigator).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •(i)Individuals with type 1, gestational or monogenic diabetes mellitus
- •(ii)eGFR < 60 ml.min-1 per 1.73m2 or as per licencing at the point of prescription
- •(iii)Individuals with familial renal glycosuria
- •(iv)Documented or self-reported cirrhosis
- •(v)Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •(vi)Individual with recurrent balanitis, vaginal or urinary tract infections
- •(vii)Current or planned pregnancy, or breast feeding
- •(viii)Females of childbearing age, unwilling to use adequate contraceptive methods during the study period
- •(ix)Currently on SLGT2i, GLP-1RA, basal-bolus or premixed insulin therapies
- •(x)Contra-indications to exercise or SGLT2i therapy
- •(xi)Current participation in another research study with investigational medical product
- •(xii)Scoring 0 on the SPPB, or otherwise unable to complete the test due to severe functional limitations
- •(xiii)Active malignancy; at discretion of study clinician
- •(xiv)Serious illness with life-expectancy < 1 year or other significant illness which, in the opinion of a study clinician, precludes involvement
- •(xv)Individuals with history of chronic pancreatitis
- •(xvi)Individuals with Latent Autoimmune Diabetes in Adults (LADA)
- •(xvii)Patients with a history of excessive alcohol consumption
- •(xviii)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)
- •(i) 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)
- •(i)Individuals taking any medication that, in the opinion of a study clinician, preclude involvement in the muscle biopsy sub-study (including blood thinning medications).
- •(ii)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).
- •(iii)Individuals with a documented or self-reported history of local anaesthetic sensitivity.
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