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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

986 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Care Group

Subjects undergo usual standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Intervention with exercise, dietary and educational programs

Group Type EXPERIMENTAL

Exercise, dietary and educational program

Intervention Type BEHAVIORAL

Interventions

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Exercise, dietary and educational program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No