Dapagliflozin, Exercise Training and physicAl function: the DETA trial.

Phase 1

• Conditions: Frailty 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 disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-004586-41-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-13
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

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)
(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

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
(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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified