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

NCT ID: NCT01144078

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-06-30

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Intensity Interval Exercise

This arms receives the High Intensity Interval Exercise intervention

Group Type: EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type: BEHAVIORAL

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.

Traditional Intensity Exercise

This arms receives the Traditional Intensity Exercise intervention

Group Type: EXPERIMENTAL

Traditional Intensity Exercise

Intervention Type: BEHAVIORAL

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.

Interventions

Traditional 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.

Intervention Type: BEHAVIORAL

High Intensity Interval Exercise

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Low Intensity Exercise; Moderate Intensity Exercise

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Diabetes Institute

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Normand Boule

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Normand G. Boulé, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23984433 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23183390 (View on PubMed)

Other Identifiers

ADI-2010

Identifier Type: -

Identifier Source: org_study_id