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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 : Active, not recruiting
First Posted : July 31, 2012
Last Update Posted : March 23, 2016
Information provided by (Responsible Party):

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
Type 2 Diabetes Mellitus Behavioral: Exercise, dietary and educational program

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
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

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 :
  1. 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 :
  1. Lawton Instrumental Activity of Daily Living (IADL) scale [ Time Frame: 2 years ]
  2. Barthel index of activities of daily living [ Time Frame: 2 years ]
  3. Euro-Quality of Life (QoL) index [ Time Frame: 2 years ]
  4. 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).

  5. 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)

  6. Hospital admissions [ Time Frame: 2 years ]
    Episodes of hospital admission (i.e., any admission involving an overnight stay)

  7. 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).

  8. Caregiver Strain Index [ Time Frame: 2 years ]
    Burden of the carer, as assessed by the modified Caregiver Strain Index

  9. 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   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Hospital Universitario de Getafe
Madrid, Getafe, Spain, 28905
Sponsors and Collaborators
Hospital Universitario Getafe
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
Principal Investigator: Leocadio Rodríguez Mañas, MD Hospital Universitario de Getafe
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01654341     History of Changes
Obsolete Identifiers: NCT01541787
Other Study ID Numbers: MID-Frail
278803-2 ( Other Identifier: European Commission: CORDIS: Seventh Framework Programme (FP7) )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases