NCT04332302

Brief Summary

Diabetes is a disease with a high impact in the population older than 65 years old. Some indications suggest that diabetes in the old age aggravate the negative effects of ageing, as the loss of muscle mass and strength, bringing the patients to a situation of vulnerability and elevated risk of disability and death known as "frailty syndrome". Recently, scientists have observed that if older population train with musculation machines emphasising the muscular power, it is possible to have an impact on a disminution of frailty and restoring the physical functionality. This project deeps in the physiological and molecular mechanisms that underlie to improvements in the frail diabetic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

March 30, 2020

Last Update Submit

October 16, 2020

Conditions

Diabetes Mellitus, Type 2Frailty

Keywords

Resistance TrainingQuality of LifeMolecular GeneticsSkeletal Muscle

Outcome Measures

Primary Outcomes (14)

  • Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks

    Percentage

    0 and 12 weeks.

  • Change from Baseline Homeostasis Model Assessment - Beta cells (HOMA2-B) at 12 weeks

    Percentage

    0 and 12 weeks.

  • Change from Baseline Homeostasis Model Assessment - Insuline Resistance (HOMA2-IR) at 12 weeks

    Percentage

    0 and 12 weeks.

  • Change from Baseline Fried frailty score at 6 and 12 weeks

    Level of frailty assessed by Fried Criteria. Intermediate or prefrail: 1 or 2 criteria present. Positive for frailty phenotype: ≥3 criteria present.

    0, 6 and 12 weeks.

  • Change from Baseline Functional capacity at 6 and 12 weeks

    Level of functional capacity assessed by the test SPPB. Scores 0-3: Very low physical function; Scores 4-6: Low physical function; Scores 7-9: Moderate physical function; Scores 10-12: High physical function

    0, 6 and 12 weeks.

  • Change from Baseline Disability at 6 and 12 weeks

    Level of disability assessed by the Barthel test. A participant scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.

    0, 6 and 12 weeks.

  • Functional mobility at 6 and 12 weeks

    Level of functional mobility assessed by the Lawton test. A scale from 0 to 8, expressing higher scores better levels of independence.

    0, 6 and 12 weeks.

  • Change from Baseline Muscular power at 6 and 12 weeks

    Watts.

    0, 6 and 12 weeks.

  • Change from Baseline Levels of strength at 6 and 12 weeks

    Load (kg).

    0, 6 and 12 weeks.

  • Change from Baseline Bone Mineral Density at 12 weeks

    g/cm3

    0 and 12 weeks.

  • Change from Baseline Pigment Epitelium Derived Factor (PEDF) at 12 weeks

    Circulating level of PDEF assessed by Western Blot.

    0 and 12 weeks.

  • Genotyping of TCF7L2 (rs7903146)

    Assessed by Real-time PCR.

    0 week.

  • Genotyping of TM6SF2 (rs10401969)

    Assessed by Real-time PCR.

    0 week.

  • Genotyping of HLA (rs2854275)

    Assessed by Real-time PCR.

    0 week.

Secondary Outcomes (10)

  • Change from Baseline Body Mass Index at 6 and 12 weeks

    0, 6 and 12 weeks.

  • Change from Baseline Waist circumference at 6 and 12 weeks

    0, 6 and 12 weeks.

  • Change from Baseline Blood pressure (systolic and diastolic) at 6 and 12 weeks

    0, 6 and 12 weeks.

  • Change from Baseline Concentration of Triglycerides at 12 weeks

    0 and 12 weeks.

  • Change from Baseline Concentration of Total Cholesterol at 12 weeks

    0 and 12 weeks.

  • +5 more secondary outcomes

Study Arms (2)

Power training group

EXPERIMENTAL

Participants will be enrolled in a resistance training program.

Other: Power resistance training

Control group

NO INTERVENTION

Participants will be doing their normal life.

Interventions

Power resistance trainingOTHER

Participants will take part in an intervention of 12 weeks duration in which they will train with musculation machines.

Power training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Sign an informed consent.
  • Older than 65 years old with Type 2 Diabetes Mellitus diagnosed in a minimum of 2 previous years.
  • Being diagnosed frail, pre-frail or no frail.

You may not qualify if:

  • Barthel's index lower than 60 points.
  • Incapacity to complete the SPPB fitness test.
  • Score lower than 20 points in the Mini Mental State Examination.
  • Cardiovascular event in the previous 6 months following the New York Heart Association (NYHA) classification.
  • Patients clinically unstable by the investigator's judgement.
  • Terminal disease (life expectancy lower than 6 months).
  • Participation in another study that could interfere in the results of the current research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Educación Física

Madrid, 28040, Spain

Location

Related Publications (8)

  • Guadalupe-Grau A, Carnicero JA, Gomez-Cabello A, Gutierrez Avila G, Humanes S, Alegre LM, Castro M, Rodriguez-Manas L, Garcia-Garcia FJ. Association of regional muscle strength with mortality and hospitalisation in older people. Age Ageing. 2015 Sep;44(5):790-5. doi: 10.1093/ageing/afv080. Epub 2015 Jul 11.

    PMID: 26163682BACKGROUND

  • Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.

    PMID: 24598478BACKGROUND

  • Garcia-Garcia FJ, Gutierrez Avila G, Alfaro-Acha A, Amor Andres MS, De Los Angeles De La Torre Lanza M, Escribano Aparicio MV, Humanes Aparicio S, Larrion Zugasti JL, Gomez-Serranillo Reus M, Rodriguez-Artalejo F, Rodriguez-Manas L; Toledo Study Group. The prevalence of frailty syndrome in an older population from Spain. The Toledo Study for Healthy Aging. J Nutr Health Aging. 2011 Dec;15(10):852-6. doi: 10.1007/s12603-011-0075-8.

    PMID: 22159772BACKGROUND

  • Losa-Reyna J, Baltasar-Fernandez I, Alcazar J, Navarro-Cruz R, Garcia-Garcia FJ, Alegre LM, Alfaro-Acha A. Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. Exp Gerontol. 2019 Jan;115:114-121. doi: 10.1016/j.exger.2018.11.022. Epub 2018 Dec 4.

    PMID: 30528641BACKGROUND

  • Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Rodriguez-Gomez I, Navarro-Cruz R, Losa-Reyna J, Garcia-Garcia FJ, Alegre LM. Force-velocity profiling in older adults: An adequate tool for the management of functional trajectories with aging. Exp Gerontol. 2018 Jul 15;108:1-6. doi: 10.1016/j.exger.2018.03.015. Epub 2018 Mar 20.

    PMID: 29567100BACKGROUND

  • Alcazar J, Guadalupe-Grau A, Garcia-Garcia FJ, Ara I, Alegre LM. Skeletal Muscle Power Measurement in Older People: A Systematic Review of Testing Protocols and Adverse Events. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):914-924. doi: 10.1093/gerona/glx216.

    PMID: 29309534BACKGROUND

  • Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Manas-Bote A, Guadalupe-Grau A, Garcia-Garcia FJ, Alegre LM. The Force-Velocity Relationship in Older People: Reliability and Validity of a Systematic Procedure. Int J Sports Med. 2017 Dec;38(14):1097-1104. doi: 10.1055/s-0043-119880. Epub 2017 Nov 10.

    PMID: 29126339BACKGROUND

  • Guadalupe-Grau A, Aznar-Lain S, Manas A, Castellanos J, Alcazar J, Ara I, Mata E, Daimiel R, Garcia-Garcia FJ. Short- and Long-Term Effects of Concurrent Strength and HIIT Training in Octogenarians with COPD. J Aging Phys Act. 2017 Jan;25(1):105-115. doi: 10.1123/japa.2015-0307. Epub 2016 Aug 24.

    PMID: 27402660BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Frailty

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amelia Guadalupe Grau, PhD

    Technical University of Madrid

    PRINCIPAL INVESTIGATOR

  • Carmen Ramírez Castillejo, PhD

    Technical University of Madrid

    STUDY CHAIR

  • Marcela González Gross, Professor

    Technical University of Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

January 15, 2020

Primary Completion

May 15, 2020

Study Completion

December 21, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Individualised report to all the participants after the completion of the study.

Shared Documents
ANALYTIC CODE
Time Frame
At the end of the intervention.
Access Criteria
The participants who have accepted to have the report.

Locations

ES(1)