Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/03/2016
Date assigned
05/04/2016
Last edited
05/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a life-long condition where a person is unable to control their blood sugar levels. There are type main types of diabetes. In type 1 diabetes the body is unable to produce a hormone called insulin, which is responsible for breaking down glucose and turning it into energy. In type 2 diabetes the body either does not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). There is a lot of evidence showing that regular exercise and a healthy diet can help control blood sugar, as well as offering other benefits such as improving cardiovascular (heart and blood vessels) health, reducing the risk of heart attack and stroke. The aim of this study is to find out whether aerobic exercise and diet on blood sugar control and cardiovascular health in male patients with type 1 or type 2 diabetes.

Who can participate?
Males with type 1 or type 2 diabetes aged nine years and over.

What does the study involve?
Participants are divided into one of two groups, based on the order that they sign up for the study. Those in the first group (who signed up first) take part in a 12 week course of exercise and dieting. The diet consists of following food recommendations for diabetic patients, namely low calorie intake and avoiding high sugar and saturated fat. The exercise involves 50-minute exercise sessions three times a week, which involves running on a treadmill. Those in the second group continue with their lives as usual for the 12 weeks of the study. At the start of the study and then again after 12 weeks, participants in both groups are weighed and have a blood test to test their blood sugar levels after they have not eaten or drunk anything for 12 hours (fasting).

What are the possible benefits and risks of participating?
Participants may benefit from an improvement in blood sugar control and cardiovascular health. There is a risk that during exercise blood sugar could drop below healthy levels, however this is will be carefully monitored.

Where is the study run from?
1. King Fahd University of Petroleum and Minerals (Saudi Arabia)
2. King Fahd University Hospital (Saudi Arabia)

When is the study starting and how long is it expected to run for?
January 2013 to May 2013

Who is funding the study?
Investigator initiated and funded (Saudi Arabia)

Who is the main contact?
Dr Mohammed Hamdan Hashem Mohammed
hamdan@kfupm.edu.sa

Trial website

Contact information

Type

Public

Primary contact

Dr Mohammed Hamdan Hashem Mohammed

ORCID ID

Contact details

Alexandria University
Faculty of Physical Education for Men
Abu Qir
Alexandria
21913
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of aerobic exercise with diet on blood sugar control and cardiovascular health of male patients with type 1 and 2 diabetes mellitus: A parallel group randomized control trial

Acronym

Study hypothesis

A 12-week aerobic exercise program combined with a diet will significantly improve the glycemic control and cardiovascular health of the patients.

Ethics approval

Ethical Committee of the Department of Biological and Sport Health Science, Alexandria University, Egypt, 13/05/2012

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Diabetes mellitus

Intervention

Participants are divided into one of two groups in a 1:1 ratio. The patients who registered first are in the intervention group.

Intervention group: Participants complete a combination of 50-minute exercise sessions done three times a week for 12 weeks (17 February-8 May 2013) and diet. The patients in the control group were asked to continue with their daily activities. The exercise program involves aerobic exercises on treadmills. This involves a 5 minute warm up and cool down before and after the exercise. The exercise intensity was increased progressively: 40-60% in the first four weeks, 60-70% in the second four weeks, and 70-90% in the last four weeks. The increase depended on the ability of the patients. The diet consists of food recommendations for diabetic patients. It provides the amount of calories for the patients to reach and maintain their ideal weight. Each patient has a number of calories to consume, depending on the target weight ideal body weight they need to reach or maintain during and at the end of the program. The patients have the following caloric options: 1200, 1400, 1500 and 1800 calories. The body weight of the patients is measured weekly in order to determine if the patients followed the diet program. Each patient is expected to attain a weekly target body weight if they followed the diet recommendations. The patients are advised to avoid foods with high sugar and saturated fat content.

Control group: Participants continue with their daily activities alone.

Participants are followed up at 12 weeks to have their glycemic control and cardiovascular health assessed.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Glycemic control is assessed by measuring HbA1c and fasting blood glucose after a 12-hour fast using Dimension® RxL Max® at baseline and 12 weeks

Secondary outcome measures

1. Cardiovascular health is assessed at baseline and 12 weeks:
1.1. Resting heart rate is measured manually at the radial artery (number of beats in 15 seconds was multiplied by four)
1.2. Systolic and diastolic blood pressures are measured using a sphygmomanometer
1.3. Blood lipid profile is measured after a 12-hour fast using Dimension® RxL Max®
2. Body mass is measured using a weighing scale at baseline and 12 weeks
3. Body mass index is calculated using the formula mass/height2 at baseline and 1 weeks

Overall trial start date

01/01/2013

Overall trial end date

08/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males, aged 9 years and over
2. Diagnosis of type 1 and type 2 diabetes mellitus for more than one year
3. Absence of chronic diseases such as retinopathy, neuropathy, asthma, arthritis, morbid obesity and cardiovascular disease
4. Able to attend study centre

Participant type

Patient

Age group

Mixed

Gender

Male

Target number of participants

60

Participant exclusion criteria

1. Aged under 9 years
2. Diabetes diagnosis for less than one year
3. Chronic diseases such as retinopathy, neuropathy, asthma, arthritis, morbid obesity and cardiovascular disease.
4. Those unable to attend the study centre

Recruitment start date

01/01/2013

Recruitment end date

01/02/2013

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

King Fahd University of Petroleum and Minerals
Dhahran
31261
Saudi Arabia

Trial participating centre

King Fahd University Hospital
Bashar Ibn Burd St
Al Khobar
34445
Saudi Arabia

Sponsor information

Organisation

Alexandria University

Sponsor details

Ethical Committee of the Department of Biological and Sport Health Science
Faculty of Physical Education for Men
Alexandria
21913
Egypt

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in refereed journals.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes