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

NCT01144078 | Completed

• 1 other identifier: ADI-2010
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Adiposity; Exercise training; Older adults

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• 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

Study Arms (2)

High Intensity Interval Exercise

EXPERIMENTAL

This arms receives the High Intensity Interval Exercise intervention

Behavioral: High Intensity Interval Exercise

Traditional Intensity Exercise

EXPERIMENTAL

This arms receives the Traditional Intensity Exercise intervention

Behavioral: Traditional Intensity Exercise

Interventions

Traditional Intensity Exercise 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.

Also known as: Low Intensity Exercise, Moderate Intensity Exercise

Traditional Intensity Exercise

High Intensity Interval Exercise 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.

High Intensity Interval Exercise

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Diabetes Institute: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

Location

Related Publications (2)

• 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.

  PMID: 23984433 DERIVED

• 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.

  PMID: 23183390 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Normand G. Boulé, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

CA (1)