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

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144078
• Other study ID #: ADI-2010
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: January 2, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Diabetes Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of these exercise interventions in people with type 2 diabetes	Recruitment; Adherence; Retention	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.	Yes
Secondary	Intra-abdominal fat	Intra-abdominal fat will be estimated by previously validated technique of combining DXA and anthropometric measurements (Bertin 2000)	During the week before and the week after the 14 week exercise interventions	No
Secondary	Glycated hemoglobin (A1c)		During the week before and the week after the 14 week exercise interventions	No
Secondary	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.	Before and after individual exercise sessions	Yes
Secondary	Plasma lipids and lipoproteins	HDL cholesterol; LDL cholesterol; Total cholesterol; Triglycerides	During the week before and the week after the 14 week exercise interventions	No
Secondary	Daily steps	Daily steps will be measured with a Yamax SW-200Digiwalker Pedometer.	During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions	No
Secondary	Dietary intake	Dietary intake will be estimated by a standard 3-day food record (2 weekdays and 1 weekend).	During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions	No
Secondary	Anthropometrics	Anthropometrics will include: height, weight, waist circumference and hip circumference.	During the week before and the week after the 14 week exercise interventions	No
Secondary	Blood pressure		During the week before and the week after the 14 week exercise interventions	No
Secondary	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).	During the week before and the week after the 14 week exercise interventions	No
Secondary	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.	During week 1, week 8 and week 14 of the exercise interventions	No