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

Hospital Universitario Getafe

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Behavioral: Exercise, dietary and educational program

Study type

Interventional

Funder types

Other

Identifiers

NCT01654341

278803-2 (Other Identifier)

MID-Frail

Details and patient eligibility

About

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.

Full description

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.

Enrollment

986 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.