Clinical trial NCT01144078: Exercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Adiposity
Exercise training
Older adults
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Diabetes Institute
First posted: 2010-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility of these exercise interventions in people with type 2 diabetes
timeFrame: 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:
measure: Intra-abdominal fat
timeFrame: During the week before and the week after the 14 week exercise interventions
measure: Glycated hemoglobin (A1c)
timeFrame: During the week before and the week after the 14 week exercise interventions
measure: Glucose
timeFrame: Before and after individual exercise sessions
measure: Plasma lipids and lipoproteins
timeFrame: During the week before and the week after the 14 week exercise interventions
measure: Daily steps
timeFrame: During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions
measure: Dietary intake
timeFrame: During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions
measure: Anthropometrics
timeFrame: During the week before and the week after the 14 week exercise interventions
measure: Blood pressure
timeFrame: During the week before and the week after the 14 week exercise interventions
measure: Fitness
timeFrame: During the week before and the week after the 14 week exercise interventions
measure: Exercise Self-efficacy
timeFrame: During week 1, week 8 and week 14 of the exercise interventions
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Normand G. Boulé, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.