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Completed

NCT Number: NCT01654341

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

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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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Getafe

Madrid, Getafe, 28905, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise, dietary and educational program

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Collaborators

  • Cardiff University
  • Catholic University of the Sacred Heart
  • Diabetes Frail Ltd
  • Hexabio Sarl
  • Igen Biotech SL
  • Niche Science & Technology Ltd
  • University Ghent
  • University Hospital, Bordeaux
  • University Hospital, Toulouse
  • University of Campania Luigi Vanvitelli
  • University of Castilla-La Mancha
  • University of Ulm
  • Univerzita Karlova v Praze
  • Vrije Universiteit Brussel

Registry information

Official study 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

Acronym: MID-Frail

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2012
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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