Power Strength Training in Type 2 Diabetic Mellitus Older Adults (DIAPOW)

October 16, 2020 updated by: Amelia Guadalupe Grau, Technical University of Madrid

Effects of an Exercise Program on Physical Functionality and Frailty in Type 2 Diabetic Older Adults. Role of Circulating Concentration of PDEF and Differential Genes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is hypothesised that:

  1. High intensity training (strength-power) prescribed properly in an individualised form and supervised could influence significantly on the phenotypic response in the DM type 2: decreasing the level of clinical severity, disability and frailty, improving quality of life and glycaemic control, functional capacity and body composition (especially the muscle mass) of the diabetic patients (type 2) older than 65 years old.
  2. Part of the training adaptations in diabetic patients (type 2) older than 65 years old could due to physiological conditions as the systemic level of biomarkers as PDEF in these patients.
  3. Part of the training adaptations in diabetic patients (type 2) could be influenced by the characterisation of associated genes to the different types of DM type 2 recently characterised.

The principal aims are:

  1. To evaluate the effectiveness of a novel intervention based on strength-power exercise in individuals older than 65 years old with DM type 2 and frailty in term of: level of clinical severity, disability, glycaemic control, quality of life, functional capacity, state of frailty and body composition.
  2. To establish whether PDEF serves as diagnostic and prediction biomarker to training response, providing an objective and accessible method that would stratify the response to the intervention helping with the patients screening.
  3. To determine the role of characterised genetic variants in the different subgroups of DM type 2 in the level of response to the training stimuli.

Study design Longitudinal intervention stratified study, controlled and single-blinded, with a group of intervention and control group.

Based on data from a previous study recently published by the collaborators of this project. The sample size was calculated to get statistically significant differences in the physical functionality using ANCOVA and performing a bilateral contrast with alpha=0.05 of the effect of the group (with any of the independent variables), and it is needed 30 subjects by group (total n=60) to get a statistical power of 80%, with a partial eta ≥ 0.101 (value that corresponds with the size of the moderate effect).

Exercise program The intervention period will have a duration of 12 weeks, in which the training group will perform 2 sessions per week (24 sessions in total), while the control group will not perform any type of intervention, following their normal lifes and the habitual medical cares. The experimental group will perform a program focused on the muscle power training, in which there will be included exercise of upper limbs (chest press) and lower limbs (leg press). The exercises will be performed in muscle-building machines available in the reference institutions of the collaborators. It is important to point out that the intensity in the exercises will be individualised for any patient through a test of determination of muscle power validated previously by the consortium of researchers and the subjects will perform the exercises at this intensity at which the subjects will develop their maximal muscle performance, with the performance of 3-4 bouts of 8 repetitions in each exercise. After the third week of intervention, it will be put the attention to the speed of execution. The duration of each session has been estimated in 20-30 minutes.

Finally, the subjects in the control group will serve to compare the interventions with exercise and the clinical conventional treatment, as well as to determine whether the training program is able to restore the functional capacity in a similar way in diabetic patients without frailty.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Instituto Nacional de Educación Física

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Power training group
Participants will be enrolled in a resistance training program.
Other: Power resistance training
Participants will take part in an intervention of 12 weeks duration in which they will train with musculation machines.
No Intervention: Control group
Participants will be doing their normal life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks
Time Frame: 0 and 12 weeks.
Percentage
0 and 12 weeks.
Change from Baseline Homeostasis Model Assessment - Beta cells (HOMA2-B) at 12 weeks
Time Frame: 0 and 12 weeks.
Percentage
0 and 12 weeks.
Change from Baseline Homeostasis Model Assessment - Insuline Resistance (HOMA2-IR) at 12 weeks
Time Frame: 0 and 12 weeks.
Percentage
0 and 12 weeks.
Change from Baseline Fried frailty score at 6 and 12 weeks
Time Frame: 0, 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
Time Frame: 0, 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
Time Frame: 0, 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
Time Frame: 0, 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
Time Frame: 0, 6 and 12 weeks.
Watts.
0, 6 and 12 weeks.
Change from Baseline Levels of strength at 6 and 12 weeks
Time Frame: 0, 6 and 12 weeks.
Load (kg).
0, 6 and 12 weeks.
Change from Baseline Bone Mineral Density at 12 weeks
Time Frame: 0 and 12 weeks.
g/cm3
0 and 12 weeks.
Change from Baseline Pigment Epitelium Derived Factor (PEDF) at 12 weeks
Time Frame: 0 and 12 weeks.
Circulating level of PDEF assessed by Western Blot.
0 and 12 weeks.
Genotyping of TCF7L2 (rs7903146)
Time Frame: 0 week.
Assessed by Real-time PCR.
0 week.
Genotyping of TM6SF2 (rs10401969)
Time Frame: 0 week.
Assessed by Real-time PCR.
0 week.
Genotyping of HLA (rs2854275)
Time Frame: 0 week.
Assessed by Real-time PCR.
0 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Body Mass Index at 6 and 12 weeks
Time Frame: 0, 6 and 12 weeks.
Kg by square meters.
0, 6 and 12 weeks.
Change from Baseline Waist circumference at 6 and 12 weeks
Time Frame: 0, 6 and 12 weeks.
Meters.
0, 6 and 12 weeks.
Change from Baseline Blood pressure (systolic and diastolic) at 6 and 12 weeks
Time Frame: 0, 6 and 12 weeks.
mmHg.
0, 6 and 12 weeks.
Change from Baseline Concentration of Triglycerides at 12 weeks
Time Frame: 0 and 12 weeks.
mg/dL.
0 and 12 weeks.
Change from Baseline Concentration of Total Cholesterol at 12 weeks
Time Frame: 0 and 12 weeks.
mg/dL.
0 and 12 weeks.
Change from Baseline Concentration of HDL Cholesterol at 12 weeks
Time Frame: 0 and 12 weeks.
mg/dL.
0 and 12 weeks.
Change from Baseline Concentration of LDL Cholesterol at 12 weeks
Time Frame: 0 and 12 weeks.
mg/dL.
0 and 12 weeks.
Change from Baseline Subjective level of quality of life at 12 weeks
Time Frame: 0 and 12 weeks.
Level of quality of life assessed by the test EuroQoL index, EQ-5D-5L. The score is the time trade-off (TTO). Scale from 11111 to 55555 being the higher the best health related quality of life.
0 and 12 weeks.
Change from Baseline Physical activity at 12 weeks
Time Frame: 0 and 12 weeks.
Accelerometry, counts/min.
0 and 12 weeks.
Change from Baseline Balance at 12 weeks
Time Frame: 0 and 12 weeks.
Level of balance assessed in a force platform. Newtons.
0 and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Madrid

Collaborators

Castilla-La Mancha Health Service
University of Castilla-La Mancha
Spanish Society of Diabetes

Investigators

  • Principal Investigator: Amelia Guadalupe Grau, PhD, Technical University of Madrid
  • Study Chair: Carmen Ramírez Castillejo, PhD, Technical University of Madrid
  • Study Director: Marcela González Gross, Professor, Technical University of Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

May 15, 2020

Study Completion (Anticipated)

December 21, 2021

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE1911600154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

At the end of the intervention.

IPD Sharing Access Criteria

The participants who have accepted to have the report.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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