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Type 2 Diabetes MellitusNCT01144078

Exercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot Study

A study testing Traditional Intensity Exercise and High Intensity Interval Exercise in people with Type 2 Diabetes Mellitus, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Body fat is an important risk factors for type 2 diabetes. However, not all body fat is the same. Research suggests that fat stored in the abdomen is most harmful. This is known as intra-abdominal fat. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Traditional Intensity Exercise and High Intensity Interval Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
Jun 2010to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women with type 2 diabetes.
  • From 55-75 years of age (Women post-menopausal for at least 5 years).
  • Sedentary: < 3 bouts of planed physical activity of >30 min per week.

Who cannot join

  • Smoking (defined as more than one cigarette per day).
  • Inability to speak and read English.
  • Diseases known to affect body fat distribution (e.g., polycystic ovary syndrome, Cushing's syndrome, HIV-AIDS or lipodystrophies).
  • Taking medications that may affect body fat distribution (e.g., Thiazolidinedione, Insulin, Growth Hormone).
  • Limitations to regular exercise training (e.g., musculoskeletal limitations, heart disease, chronic obstructive pulmonary disease).
  • Answering "yes" to any of the questions on the physical activity readiness questionnaire (PAR-Q).
Show all 13Show fewer
  • Having undergone major changes in physical activity, diet or medication in the previous 6 months (or be planning such changes in the next 4 months). Changes in physical activity will be considered as an increase or decrease of more than 1 hour per week. A change in body weight greater 3 kg will also lead to exclusion.
  • Body weight > 300 lbs (maximum weight for Dual Energy X-Ray Absorptiometry (DXA) table).
  • HbA1c > 0.09%
  • blood pressure above 140/90 mmHg.
  • LDL cholesterol above 3.5 mmol/L or TC:HDL-C above 5.0.
  • Self-reported alcohol or substance abuse within the past twelve months, current consumption of more than 14 alcoholic drinks per week, and/or current acute treatment or rehabilitation program for these problems.
  • Other medical or psychiatric factors that in the judgment of the principal investigators may interfere with study participation or the ability to follow the study protocol.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2H9

Other trials in Canada

About this study

Body fat is an important risk factors for type 2 diabetes. However, not all body fat is the same. Research suggests that fat stored in the abdomen is most harmful. This is known as intra-abdominal fat. The objective of the proposed study is to understand the effect of exercise intensity on intra-abdominal fat and glucose control. Twenty participants with type 2 diabetes will be assigned to traditional or high intensity exercise. The exercise interventions will last a total of 14 weeks. Those in the traditional intensity group will exercise at an intensity comparable to walking. The high intensity group will alternate between 1 minute at high intensity and 3 minutes at low intensity. Both exercise groups will burn a similar amount of Calories and will exercise for the same amount of time. The exercise duration will start at 30 minutes per day. By the end of the study, it will be 60 minutes per day. All exercise sessions will be supervised. Body fat distribution will be estimated by a scanning machine called a DXA and anthropometric measures. Glycemic control will be measured from a blood sample. This study may not be of sufficient size to detect meaningful changes in these variables. However, it will provide information in regards to the preliminary efficacy, resource requirements and feasibility. Feasibility will include: recruitment, retention and adherence. Such information is essential for planning a more definitive trial. The identification of exercises that target greater reductions in abdominal fat will have important implications for the health of people with diabetes.

Being tested
Traditional Intensity Exercise, High Intensity Interval Exercise
Keywords
Adiposity, Exercise training, Older adults
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional Intensity ExerciseBehavioural

    Also called Low Intensity Exercise, Moderate Intensity Exercise

    The exercise intensity will be set at a workload corresponding to 40% of the workload obtained at VO2peak during the baseline progressive maximal exercise tests. Based on the anticipated fitness of the participants this should to an intensity of about 3.5 METs, which is similar to walking at a moderate pace.

  • High Intensity Interval ExerciseBehavioural

    The High Intensity Interval Exercise intervention will replicate all aspects of the Traditional Intensity Exercise with the exception of exercise intensity. The High Intensity Interval Exercise protocol will involve alternating between 1-minute intervals at 100% workload obtained at VO2peak followed by 3-minute recovery intervals at 20% of workload obtained at VO2peak (average = 40% ). As many complete intervals as possible will be completed during a training session (e.g., 7 intervals can be completed in a 30 min period (7 x 4 min = 28 min), with the remaining time spent at 40% peak workload to ensure a similar work output as the Traditional Intensity Exercise.

Study groups in NCT01144078
Study groupRoleWhat they receive
High Intensity Interval ExerciseExperimentalThis arms receives the High Intensity Interval Exercise intervention
Receives: Behavioral: High Intensity Interval Exercise
Traditional Intensity ExerciseExperimentalThis arms receives the Traditional Intensity Exercise intervention
Receives: Behavioral: Traditional Intensity Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of these exercise interventions in people with type 2 diabetes

    • Recruitment
    • Adherence
    • Retention

    Measured: The feasibility of recruiting will be assessed over the 12-month recruitment phase. Adherence will be measured throughout the 14-week interventions. Retention will consider those who participate in the assessments before and after the intervention.

Secondary outcomes (10)

  1. Intra-abdominal fat

    Intra-abdominal fat will be estimated by previously validated technique of combining DXA and anthropometric measurements (Bertin 2000)

    Measured: During the week before and the week after the 14 week exercise interventions

  2. Glycated hemoglobin (A1c)

    Measured: During the week before and the week after the 14 week exercise interventions

  3. Glucose

    Throughout the intervention period, we will take regular capillary blood glucose and lactate measures with a OneTouch® Ultra (LifeScan; Milpitas, CA, USA) portable glucose analyzer and a Accusport® (Boehringer Mannheim, Castle Hill, Australia) portable lactate analyzer. Samples will be taken 5 minutes before and 5 minutes after the exercise bout.

    Measured: Before and after individual exercise sessions

  4. Plasma lipids and lipoproteins

    • HDL cholesterol
    • LDL cholesterol
    • Total cholesterol
    • Triglycerides

    Measured: During the week before and the week after the 14 week exercise interventions

  5. Daily steps

    Daily steps will be measured with a Yamax SW-200Digiwalker Pedometer.

    Measured: During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions

  6. Dietary intake

    Dietary intake will be estimated by a standard 3-day food record (2 weekdays and 1 weekend).

    Measured: During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions

  7. Anthropometrics

    Anthropometrics will include: height, weight, waist circumference and hip circumference.

    Measured: During the week before and the week after the 14 week exercise interventions

  8. Blood pressure

    Measured: During the week before and the week after the 14 week exercise interventions

  9. Fitness

    A graded maximal cycle ergometer test will be conducted on a cycle ergometer. The test will begin at a pedal rate of 60-65 rpm and a resistance of 0 kp. Pedaling rate will remain constant but resistance will increase by 0.5 kp every 2 min until exhaustion. Respiratory gases will be analyzed throughout (TrueMax; ParvoMedics, Salt Lake City, UT, USA). Heart rate was continuously monitored with a polar heart rate monitor (Polar Electro, NY, USA).

    Measured: During the week before and the week after the 14 week exercise interventions

  10. Exercise Self-efficacy

    A series of questions will be used to obtain preliminary information on the acceptability of the exercise protocols to the participants. The questions will include rating of perceived exertion (Borg Scale), as well as several indications of the participants confidence in being able to complete such exercise on a regular basis, including coping, task and scheduling self-efficacy. Other questions that related to fatigue will also be asked.

    Measured: During week 1, week 8 and week 14 of the exercise interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144078
Sponsor's protocol ID
ADI-2010
Status last verified
Jan 2012
First submitted
7 Jun 2010
Last updated
5 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Terada T, Friesen A, Chahal BS, Bell GJ, McCargar LJ, Boule NG. Exploring the variability in acute glycemic responses to exercise in type 2 diabetes. J Diabetes Res. 2013;2013:591574. doi: 10.1155/2013/591574. Epub 2013 Jul 29.

    PubMed 23984433

  • Terada T, Friesen A, Chahal BS, Bell GJ, McCargar LJ, Boule NG. Feasibility and preliminary efficacy of high intensity interval training in type 2 diabetes. Diabetes Res Clin Pract. 2013 Feb;99(2):120-9. doi: 10.1016/j.diabres.2012.10.019. Epub 2012 Nov 24.

    PubMed 23183390

Questions about this trial

What is this clinical trial studying?

A study testing Traditional Intensity Exercise and High Intensity Interval Exercise in people with Type 2 Diabetes Mellitus, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of these exercise interventions in people with type 2 diabetes (time frame: The feasibility of recruiting will be assessed over the 12-month recruitment phase. Adherence will be measured throughout the 14-week interventions. Retention will consider those who participate in the assessments before and after the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144078, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.

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