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Clinical Trials/NCT01144078
NCT01144078
Completed
Not Applicable

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

University of Alberta1 site in 1 country15 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
University of Alberta
Enrollment
15
Locations
1
Primary Endpoint
Feasibility of these exercise interventions in people with type 2 diabetes
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Normand Boule

PhD

University of Alberta

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.

Outcomes

Primary Outcomes

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.

* Recruitment * Adherence * Retention

Secondary Outcomes

  • Intra-abdominal fat(During the week before and the week after the 14 week exercise interventions)
  • Glycated hemoglobin (A1c)(During the week before and the week after the 14 week exercise interventions)
  • Glucose(Before and after individual exercise sessions)
  • Plasma lipids and lipoproteins(During the week before and the week after the 14 week exercise interventions)
  • Daily steps(During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions)
  • Dietary intake(During the week before the 14 week exercise interventions as well as during week 8 and week 14 of the interventions)
  • Anthropometrics(During the week before and the week after the 14 week exercise interventions)
  • Blood pressure(During the week before and the week after the 14 week exercise interventions)
  • Fitness(During the week before and the week after the 14 week exercise interventions)
  • Exercise Self-efficacy(During week 1, week 8 and week 14 of the exercise interventions)

Study Sites (1)

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