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Type 2 Diabetes MellitusMID-FrailNCT01654341

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

A study testing Exercise, dietary and educational program in people with Type 2 Diabetes Mellitus, run by Hospital Universitario Getafe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Exercise, dietary and educational program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
986 participants
Where
1 siteSpain
Study dates
Dec 2013to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de Getafe

    Madrid, Getafe, 28905

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Exercise, dietary and educational program
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise, dietary and educational programBehavioural

Study groups in NCT01654341
Study groupRoleWhat they receive
Usual Care GroupNo interventionSubjects undergo usual standard of care
Intervention GroupExperimentalIntervention with exercise, dietary and educational programs
Receives: Behavioral: Exercise, dietary and educational program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in summary ordinal score on the Short Physical Performance Battery test

    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.

    Measured: 2 years

Secondary outcomes (9)

  1. Lawton Instrumental Activity of Daily Living (IADL) scale

    Measured: 2 years

  2. Barthel index of activities of daily living

    Measured: 2 years

  3. Euro-Quality of Life (QoL) index

    Measured: 2 years

  4. Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life,

    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).

    Measured: 2 years

  5. Symptomatic hypoglycaemia

    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)

    Measured: 2 years

  6. Hospital admissions

    Episodes of hospital admission (i.e., any admission involving an overnight stay)

    Measured: 2 years

  7. Episodes of permanent institutionalization

    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).

    Measured: 2 years

  8. Caregiver Strain Index

    Burden of the carer, as assessed by the modified Caregiver Strain Index

    Measured: 2 years

  9. Mortality

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2012 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
986 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01654341
Sponsor's protocol ID
MID-Frail
Other IDs
278803-2
Acronym
MID-Frail
Status last verified
Mar 2019
First submitted
27 Jul 2012
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • Laosa O, Topinkova E, Bourdel-Marchasson I, Vellas B, Izquierdo M, Paolisso G, Hardman T, Zeyfang A, Pedraza L, Carnicero JA, Rodriguez-Manas L, Sinclair AJ; MIDFRAIL consortium. Long-term frailty and physical performance transitions in older people with type-2 diabetes. The MIDFRAIL randomized clinical study. J Nutr Health Aging. 2025 Apr;29(4):100512. doi: 10.1016/j.jnha.2025.100512. Epub 2025 Feb 14.

    PubMed 39954533

  • 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.

    PubMed 31316984

  • 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.

    PubMed 24456998

Questions about this trial

What is this clinical trial studying?

A study testing Exercise, dietary and educational program in people with Type 2 Diabetes Mellitus, run by Hospital Universitario Getafe at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in summary ordinal score on the Short Physical Performance Battery test (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654341, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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