Trial record 1 of 1 for: NCT01654341

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

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ClinicalTrials.gov Identifier: NCT01654341

Recruitment Status : Unknown

Verified February 2016 by Hospital Universitario Getafe.
Recruitment status was: Active, not recruiting

First Posted : July 31, 2012

Last Update Posted : March 23, 2016

Sponsor:

Collaborators:

Cardiff University

Igen Biotech SL

University Hospital, Bordeaux

Hexabio Sarl

University of Campania "Luigi Vanvitelli"

University Hospital, Toulouse

University of Ulm

University Ghent

University of Castilla-La Mancha

Univerzita Karlova v Praze

Niche Science & Technology Ltd

Catholic University of the Sacred Heart

Vrije Universiteit Brussel

Diabetes Frail Ltd

Information provided by (Responsible Party):

Hospital Universitario Getafe

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Exercise, dietary and educational program	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	986 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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 Start Date :	December 2013
Estimated Primary Completion Date :	March 2017
Estimated Study Completion Date :	March 2017

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual Care Group Subjects undergo usual standard of care
Experimental: Intervention Group Intervention with exercise, dietary and educational programs	Behavioral: Exercise, dietary and educational program

Outcome Measures

Primary Outcome Measures :

Changes in summary ordinal score on the Short Physical Performance Battery test [ Time Frame: 2 years ]
The Short Physical Performance Battery (SPPB) is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines 3 areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. These areas represent essential tasks important for independent living and are thus an important outcome measure for patients with cardiovascular and pulmonary disease.

Secondary Outcome Measures :

Lawton Instrumental Activity of Daily Living (IADL) scale [ Time Frame: 2 years ]
Barthel index of activities of daily living [ Time Frame: 2 years ]
Euro-Quality of Life (QoL) index [ Time Frame: 2 years ]
Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life, [ Time Frame: 2 years ]
Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life, using an economic model embracing the direct health-related costs (in-patient, out-patient, pharmaceutical, etc), formal care costs (home care, respite care, day centers, etc) and the informal care costs (carer).
Symptomatic hypoglycaemia [ Time Frame: 2 years ]
Episodes of symptomatic hypoglycaemia (i.e., a recorded blood sugar less than 4 mmol/L, or symptoms or signs attributed to low blood sugar and responding to appropriate treatment)
Hospital admissions [ Time Frame: 2 years ]
Episodes of hospital admission (i.e., any admission involving an overnight stay)
Episodes of permanent institutionalization [ Time Frame: 2 years ]
Episodes of permanent institutionalization (i.e., permanent move to any care setting other than the patient's own home, where paid staff are available to provide care if needed at any time during the day or night).
Caregiver Strain Index [ Time Frame: 2 years ]
Burden of the carer, as assessed by the modified Caregiver Strain Index
Mortality [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	70 Years and older (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654341

Locations


Spain
Hospital Universitario de Getafe
Madrid, Getafe, Spain, 28905

Sponsors and Collaborators