Home » Trials » SLCTR/2015/029


A study on the effect of aerobic exercise on the adjustments of taste thresholds for sucrose among diabetics

-

SLCTR Registration Number

SLCTR/2015/029


Date of Registration

16 Dec 2015

The date of last modification

May 07, 2021


Trial Status



Application Summary


Scientific Title of Trial

A study on the effect of aerobic exercise on the adjustments of taste thresholds for sucrose among diabetics


Public Title of Trial

How exercises alter the taste


Disease or Health Condition(s) Studied

Diabetes Mellitus


Scientific Acronym

None


Public Acronym

None


Brief title

Exercise in the adjustment of taste in diabetics


Universal Trial Number

U1111-1176-290


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

23/15 (Ethics Review Committee, Faculty of Faculty of Medical Sciences, University of Sri Jayewardenepura)


Trial Details


What is the research question being addressed?

Does aerobic exercise alter the taste threshold for sucrose ?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment

Single


Purpose

Basic science


Study Phase

Not Applicable


Intervention(s) planned

Study setting will be the family practice center University of Sri Jayewardenapura.. Patient recruitment - Every 10th patient attending the family practice center who meets with the criteria will be selected.

Intervention: recruited diabetic patients will be requested to perform aerobic exercises for 6 months Duration and intensity: The subjects will be instructed to perform brisk walking individually at home for a minimum of 4 -5 days a week for 10min, 15min, 20 min, 30min at 1st,2nd,3rd and 4th week respectively.

From the 2nd month onward subjects will be instructed to perform brisk walking for a minimum of 4 - 5 days a week until 6 months.


Inclusion criteria

  1. Age 35 to 60 years
  2. Diagnosis of type 2 diabetes mellitus for more than 5 years
  3. Willing to do regular exercises

Exclusion criteria

  1. Diagnosed patients with ischemic heart disease or with evidenced of ischemic heart disease.
  2. Diagnosed mental illness and inability to answer screening questions
  3. Patients with physical or neurological disorders which will affect exercises.
  4. Those with diseases of the oral cavity
  5. Smokers and/or betel chewing
  6. Those who are on regular exercise


Primary outcome(s)

1.

1.Supra-threshold values for sucrose: using a gLMS paper scale (Green et al., 2010)

2.Preferences for sucrose: using the Monell forced-choice, paired-comparison tracking procedure (Menella et al. 2011)

[

At baseline, 3 months and 6 months

]

Secondary outcome(s)

1.
  1. Waist and hip circumferences,
  2. Blood pressure in seated position,
  3. Heart rate
  4. BMI (Body Mass Index)
  5. HbA1c(glycosylated haemoglobin)
[
  1. Waist and hip circumferences,
  2. Blood pressure in seated position,
  3. Heart rate
  4. BMI (Body Mass Index)

The above will be measures at baseline, 3 months and six months

  1. HbA1c: at baseline and six months
]

Target number/sample size

100


Countries of recruitment

Sri Lanka


Anticipated start date

2016-01-02


Anticipated end date

2016-12-02


Date of first enrollment

2016-10-10


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

University of Sri Jayewardenepura research grant (ASP/06/RE/MED/2014/15)


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2015-10-29


Approval number

23/15


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
Institutional Address:Gangodawila, Nugegoda Sri Lanka
Telephone:+94-112758000 (Extension: 4075)
Email: erc.fms.usjp@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. P. Hettiarachchi
Associate Professor
Department of Physiology, Faculty of Medical Sciences, University of SriJayewardenapura
Tel: 94-112802182
Mob: 94-71 8432344

priyadarshikahett@gmail.com

Contact Person for Public Queries

Dr. S.Wasalathanthri
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo.
Tel: 94-11 2695300
Mob: 94-7272285281

sudharshaniw@gmail.com


Primary study sponsor/organization

University of Sri Jayewardenapura

Sri Soratha Mawatha, Nugegoda 10250 Sri Lanka
Phone: 011 2 758000
Fax: +94 11 2801480
fms@sjp.ac.lk
http://www.sjp.ac.lk

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results