EUCTR2019-004586-41-GB
Active, not recruiting
Phase 1
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 sites140 target enrollmentAugust 13, 2020
ConditionsFrailty and the preceding 'pre-frail' state in patients with type 2 Diabetes Mellitus.MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsForxiga
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Frailty and the preceding 'pre-frail' state in patients with type 2 Diabetes Mellitus.
- Sponsor
- niversity of Leicester
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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)
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
The effects of exercise training combined with NR supplementation on metabolic health in older individualsNL-OMON50867niversiteit Maastricht72
Completed
Not Applicable
Impact of exercise training in combination with essential amino acid containing food on skeletal muscle volume and strength in patients with heart failure.Chronic heart failureJPRN-UMIN000023572CVI ARO30
Completed
Not Applicable
Prevention of DVT in pregnant women requires emergency cardiac surgeryIRCT20190325043107N6Tabriz University of Medical Sciences30
Completed
Not Applicable
Effects of combined exercise with and without Nigella sativa on glycemic and lipidemic control, musculoskeletal functions and biomarkers in patients with type 2 diabetesISRCTN18289389Imam Abdulrahman Bin Faisal University90
Completed
Not Applicable
The effect of combined exercise on lipid profile and total antioxidant among cardiovascular patientsPatients after Coronary Artery Bypass Graft Surgery.Atherosclerotic heart disease of native coronary arteryI25.1IRCT20190529043755N2The Isfahan University20