Clinical trial NCT01654341: Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
Collaborators: name: Cardiff University
name: Igen Biotech SL
name: University Hospital, Bordeaux
name: Hexabio Sarl
name: University of Campania Luigi Vanvitelli
name: University Hospital, Toulouse
name: University of Ulm
name: University Ghent
name: University of Castilla-La Mancha
name: Univerzita Karlova v Praze
name: Niche Science & Technology Ltd
name: Catholic University of the Sacred Heart
name: Vrije Universiteit Brussel
name: Diabetes Frail Ltd
First posted: 2012-07-31
Enrollment: 986
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in summary ordinal score on the Short Physical Performance Battery test
timeFrame: 2 years
Secondary outcomes:
measure: Lawton Instrumental Activity of Daily Living (IADL) scale
timeFrame: 2 years
measure: Barthel index of activities of daily living
timeFrame: 2 years
measure: Euro-Quality of Life (QoL) index
timeFrame: 2 years
measure: Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life,
timeFrame: 2 years
measure: Symptomatic hypoglycaemia
timeFrame: 2 years
measure: Hospital admissions
timeFrame: 2 years
measure: Episodes of permanent institutionalization
timeFrame: 2 years
measure: Caregiver Strain Index
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe
state: Getafe
Study officials:
affiliation: Hospital Universitario de Getafe
name: Leocadio Rodríguez Mañas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Regueme SC, Cowtan C, Sedgelmaci MY, Kelson M, Poustis J, Rodriguez-Manas L, Sinclair AJ, Dallaudiere B, Bourdel-Marchasson I. A Therapeutic Insole Device for Postural Stability in Older People With Type 2 Diabetes. A Feasibility Study (SENSOLE Part I). Front Med (Lausanne). 2019 Jun 27;6:127. doi: 10.3389/fmed.2019.00127. eCollection 2019.
citation: Rodriguez-Manas L, Bayer AJ, Kelly M, Zeyfang A, Izquierdo M, Laosa O, Hardman TC, Sinclair AJ, Moreira S, Cook J; MID-Frail Consortium. An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial. Trials. 2014 Jan 24;15:34. doi: 10.1186/1745-6215-15-34.