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. 2024 Nov 25;14(11):e084482. doi: 10.1136/bmjopen-2024-084482

Table 1. Eligibility criteria.

Inclusion criteria
 Age 40–75 years
 Sex Male and female
 Type 2 diabetes mellitus (T2DM) Diagnosed T2DM, treated by lifestyle management alone or in combination with monotherapy or combination oral glucose-lowering pharmacotherapies (with the exception of predefined exclusion criteria; see below)
 Haemoglobin A1c 6.5%–10% (47–86 mmol/mol) inclusive.Amended 8 October 2021 after 23 participants screened to:≤10.5% (≤91 mmol/mol)
 Frailty or functional limitation At least one of:

  1. Short Physical Performance Battery (SPPB) score 1–10 (inclusive) recorded within the preceding 5 years.26

  2. An Electronic Frailty Index coding of mild-to-moderate frailty.62

  3. Peak oxygen uptake (VO2peak) recorded within the preceding 5 years ≤18 mL/kg/min.

Amended 23 December 2021 after 28 participants screened to:Peak oxygen uptake (VO2peak) recorded within the preceding 5 below the following thresholds (as appropriate):

  • Men:

    • −<50 years: <30 mL/kg/min

    • −≥50 years: <25 mL/kg/min

  • Women:

    • −<50 years: <25 mL/kg/min

    • −≥50 years: <22 mL/kg/min

  • 4 a

    SARC-F questionnaire score ≥463
 Body mass index ≥25 kg/m2 (≥22.5 kg/m2 for south Asian ethnicity).
 Weight stable <3.kg weight change in preceding 3 months.
 Treatment stable No significant change to glucose-lowering regimen in the preceding 3 months.
 Capacity/willingness Able and willing to give informed consent.Understands spoken English.
 Exercise ability In the opinion of the investigator is able to take part in structured exercise training.
Exclusion criteria
 Other diabetes Individuals with type 1, gestational, monogenic diabetes or latent autoimmune diabetes in adults.
 Other diabetes therapies Currently taking sodium-glucose co-transporter-2 inhibitors (SGLT2i), glucagon-like peptide-1 agonists, or basal-bolus or premixed insulin therapies.
 Severe frailty Scoring 0 on the SPPB, or otherwise presenting with severe functional limitations.
 Dietary practices Adherence to a severely energy-restricted diet (<800 kilocalories per day).
 Renal impairment Estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m2 or as per licencing at the point of prescription.Amended 4 October 2023 after 141 participants screened to: eGFR<15 mL/min/1.73 m2 or as per licensing at the point of prescription.Individuals with familial renal glycosuria.
 Liver and pancreatic disorders Documented or self-reported cirrhosis.History of chronic pancreatitis.
 Cardiac disease Established heart failure.
 Dietary intolerances Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
 Genitourinary infections History of recurrent balanitis, vaginal or urinary tract infections.
 Conditions impacting weight and/or safety Active malignancy (eligibility at discretion of study clinician).Serious illness with life expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement.
 Alcohol intake History of excessive alcohol consumption.
 Contraindications to interventions Contraindications to exercise or SGLT2i therapy.
 Pregnancy and lactation Current or planned pregnancy, or breast feeding.Females of childbearing potential, unwilling to use adequate contraceptive methods during the study period.
 Participation in other trials Current participation in another research study with investigational medical product.