Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes

A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN FRAIL AND PREFRAIL OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE: THE MID-Frail STUDY

The MID-Frail STUDY project focuses on the use of interventions designed to improve functional status and enhance quality of life (rather than traditional treatments such as glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes.

Detailed Description: Subjects enrolled in the main study will also be invited to join the following sub-studies:

GENEFRAIL: this sub-study aims to determine the polymorphisms of several genes associated to frailty, in order to establish its predictive value for developing disability and response to treatment as well METABOFRAIL: this sub-study aims to investigate the metabolomic profile of frail and pre-frail patients. SARTRAIN: the combination of the assessment tools used in SARTRAIN (ARFI US, MRI, posturographic measurements) will provide a comprehensive study of the structural and functional characteristics of muscle and adjacent tissues and their change with time and the intervention. MID- POW: this sub-study aims to investigate changes in muscle power.

The project also include an randomized controlled ancillary study: SENSOLE for which the aim is to investigate the potential effects of vibrating insoles device on gait and posture.

Inclusion criteria:

• Participant is willing and able to give written informed consent for participation in the study.
• Subjects aged 70 years or older, with a diagnosis of type 2 diabetes mellitus for at least 2 years.
• Require to fulfill Fried ́s criteria for frail or pre-frail individuals.

Exclusion criteria:

• Barthel score lower than 60 points.
• Inability to carry out SPPB test (total score=0).
• Mini Mental State Examination score less than 20 points.
• Subjects unwilling or unable to consent or unable to participate safely in intervention program.
• Previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in III-IV NYHA stage.
• Clinically instable patients in the clinical judgment of the investigator.
• Terminal illness (life expectancy < 6 months).
• Any other condition that, in the clinical judgment of the investigator, means that it would not in the patient's best interests to enter the study.
• Current participation in clinical trial or any other investigational study.