Type 2 Diabetes Mellitus Clinical Trial
Official title:
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.
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