NCT03280758

Brief Summary

This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM). 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group. Muscle strengthening group will receive resistance training 3 times per week (1 hour/session). The control group will not receive any training but can continue usual medical care and daily activities. Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

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

Timeline
Completed

Started Oct 2017

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

First Submitted

Initial submission to the registry

September 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

September 5, 2017

Last Update Submit

September 11, 2017

Conditions

Keywords

Resistance trainingDiabetes Mellitusblood-glucose controlMuscleFunction

Outcome Measures

Primary Outcomes (2)

  • Fasting glucose level

    4 months

  • Lipid profiles

    HDL, LDL, Trig

    4 months

Secondary Outcomes (3)

  • Muscle strength

    4 months

  • Muscle mass

    4 months

  • Functional performance

    4 months

Study Arms (2)

Muscle strengthening group

EXPERIMENTAL

Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer.

Behavioral: Muscle Strengthening exercises

Control group

NO INTERVENTION

No exercise training.

Interventions

Participants will be required to participate in resistance training 3 hours per week.

Muscle strengthening group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T2 DM
  • years old
  • ability to perform exercise

You may not qualify if:

  • Advanced hypertension (≥ 160/100 mm Hg)
  • severe obesity (BMI ≥ 48kg/m2)
  • insulin pump user
  • coronary heart disease history
  • chronic obstructive pulmonary disease
  • advanced neuropathy
  • learning or mental disorder, or
  • any other diseases that prevent subjects from exercising safely.
  • Those who participate in regular resistance or aerobic exercises will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.

    PMID: 21705072BACKGROUND
  • Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.

    PMID: 23537893BACKGROUND
  • Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.

    PMID: 24420336BACKGROUND
  • Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.

    PMID: 12351469BACKGROUND
  • American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.

    PMID: 12017678BACKGROUND
  • Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.

    PMID: 10912903BACKGROUND
  • Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.

    PMID: 20093961BACKGROUND
  • Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.

    PMID: 12905089BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Siu Ming Fong, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siu Ming Fong, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will not know the intervention of each subjects
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 12, 2017

Study Start

October 1, 2017

Primary Completion

January 30, 2019

Study Completion

August 30, 2019

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share