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The effects of supervised progressive resistance exercise training compared to aerobic exercise training on behavioral, anthropometry, physical fitness, appetite, blood glucose control and selected biochemical parameters in Sri Lankan adults with type 2 diabetes mellitus -

SLCTR Registration Number

SLCTR/2016/017


Date of Registration

17 Jun 2016

The date of last modification

Jul 06, 2018


Trial Status



Application Summary


Scientific Title of Trial

The effects of supervised progressive resistance exercise training compared to aerobic exercise training on behavioral, anthropometry, physical fitness, appetite, blood glucose control and selected biochemical parameters in Sri Lankan adults with type 2 diabetes mellitus


Public Title of Trial

Sri Lanka Diabetes Aerobic and Resistance Training Study


Disease of Health Condition(s) Studied

Type 2 diabetes mellitus


Scientific Acronym

None


Public Acronym

SL-DARTS


Brief title

Sri Lanka Diabetes Aerobic and Resistance Training Study


Universal Trial Number

U1111-1181-7561


Any other number(s) assigned to the trial and issuing authority

ERC (Colombo): EC-14-071


Trial Details


What is the research question being addressed?

Is there a difference between supervised resistance training and aerobic training on glycosylated hemoglobin (HbA1c) levels and body fat, in Sri Lankan adults with type 2 diabetes mellitus?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Supportive care


Purpose


Intervention(s) planned

The intervention will be conducted at the University of Colombo, Sri Lanka (Gymnasium and Allied Health Sciences Unit Faculty of Medicine).

The study will have 2 intervention groups (A, B) and a control (C) group. Participants will be recruited in a roll-in method and allocated to each group using covariate-adaptive randomization.

Participants of Group A will undergo an individually supervised progressive resistance exercise program. Exercise sessions lasting 60-75 minutes will take place twice a week for a total of 12 weeks.

Participants of Group B will undergo an individually supervised progressive aerobic exercise program. Exercise sessions lasting 60-75 minutes will take place twice a week for a total of 12 weeks.

The control will not have any exercise program but will receive standard treatment of medications and nutritional advice.


Inclusion criteria

  1. Males and females aged 35-60 years.
  2. Sri Lankan origin.
  3. Diagnosed with type 2 diabetes mellitus within the last 6 years.

Exclusion criteria

  1. Blood Glycosylated hemoglobin (HbA1c) levels <7.0 % or >11.5%.
  2. History of significant cardiovascular (ischemic heart disease etc.), respiratory (asthma, chronic obstructive pulmonary disease etc) or musculoskeletal diseases (osteoarthritis of major joints etc).
  3. On insulin or thiazolidinedione therapy/other than standard oral hypoglycemic agents (metformin / sulfonylureas.).
  4. Any advanced diabetes induced end-stage organ damage (vascular, retinopathy, nephropathy, neuropathy, retinal hemorrhage or detachment, history of laser therapy).
  5. People with a cognitive impairment, an intellectual disability, or a mental illness.
  6. Current participation in supervised Resistance Training or Aerobic Training.
  7. Engaged in Resistance Training in previous 6 months.
  8. Pregnancy.


Primary outcome(s)

  1. Absolute change in HbA1c
  2. Absolute change in total body fat percentage values [measured using Dual energy x ray absorptiometry (DEXA) full body scan].

Primary outcome(s) - Time of assessment(s)

At baseline, and at the end of 12 weeks (following 24 exercise sessions).


Secondary outcome

  1. Plasma lipid profile
  2. Liver profile
  3. Muscle strength:Percentage (%) change in One Repetition Maximum (1RM).
  4. Lean mass: Dual energy x ray absorptiometry (DEXA) full body scan.
  5. Blood pressure
  6. Cardiovascular endurance: McArdle Step test and YMCA cycle ergometer test.
  7. Quality of life: SF-36 quality-of-life outcomes questionnaire
  8. Change in food preference measured by the Leeds Food Preference Questionnaire (LFPQ)

Secondary outcome(s) - Time of assessment(s)

Outcomes 1-7 will be assessed at baseline and at the end of the 12 weeks of intervention.

Outcome 8 will be assessed pre-and post-exercise session at baseline and at the final session (end of 12 weeks).



Target number/sample size

90 (30 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-08-01


Anticipated end date

2017-12-01


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Colombo on 24th July 2014 (Ref: EC-14-071). Extension granted on 30th September 2015.


Funding source

University Grants Commission Sri Lanka: UGC/DRIC/QUT 2014/CMB/01 ; University of Colombo: AP/3/2/2015/PG/04



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dilip Chathuranga Ranasinghe
Lecturer
Allied Health Sciences Unit Faculty of Medicine, University of Colombo No. 25, Kynsey Road, Colombo 0800 Sri Lanka Current PhD Candidate at School of Exercise and Nutrition Sciences & Institute of Health and Biomedical Innovation Queensland University of Technology Q Block,4WS12,Kelvin Grove, Qld 4059, Brisbane Australia.
Tel: 0094-112-688686
Mob: 0094-773-707016

chath_r@yahoo.com.au; dc.ranasinghe@hdr.qut.edu.au

Contact Person for Public Queries

Dr Prasad Katulanda
Senior Lecturer and Honorary Consultant Endocrinologist/Diabetologist
Department of Clinical Medicine Faculty of Medicine, University of Colombo, No. 25, Kynsey Road, Colombo 0800 Sri Lanka
Tel: 00 94-112-679204
Mob: 00 94-772-920991

prasad.katulanda@yahoo.com


Primary study sponsor/organization

University Grants Commission

University Grants Commission No. 20, Ward Place, Colombo 7 Sri Lanka
Tel: +94 11 3092449, +94 11 2695301

gayaniugc@gmail.com
http://www.ugc.ac.lk/

Secondary study sponsor (If any)

University of Colombo

Kumaratunga Munidasa Mawatha, Colombo Sri Lanka
Tel: 0112 586712

acpbuoc@gmail.com
http://www.cmb.ac.lk/