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| ID | Type | Description | Link |
|---|---|---|---|
| 6147 | Other Identifier | University of Colorado CTRC |
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| Name | Class |
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| Colorado Clinical & Translational Sciences Institute | OTHER |
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The investigators plan to learn more about how different levels of exercise feel to people with Type 2 Diabetes and how it feels to people without Type 2 Diabetes. This study team will also look at what causes exercise to feel harder or easier to people with and without Type 2 Diabetes. The investigators will also compare the potential benefits of supervised exercise training to that of diabetes education/blood sugar monitoring.
Exercise is a potent therapy to reduce cardiovascular mortality in Type 2 Diabetes (T2D). Although exercise is a cornerstone of treatment for T2D, people with T2D are more sedentary than similarly obese people without diabetes, for reasons that are unclear. Interventions which combined behavioral support and physical activity prescriptions successfully increased physical activity levels for people with T2D and at-risk for T2D. However, the program components which mediated increased physical activity were combined and thus the individual benefits of each component remain unknown. Given the success of these combined programs, it appears behavioral support and other psychological factors may play an important role. The study investigators are interested in the predictors of physical activity adherence in T2D as key targets for future interventions.
One likely factor which may influence physical activity adherence is perceived exercise effort. The study investigators reported, based on a small study, that perceived exercise effort is worse in people with T2D than in healthy obese controls, as measured by the Borg Rating of Perceived Exertion (RPE), even during low intensity exercise. Thus, one strategy to increase physical activity in T2D is to first identify the mediators of RPE in the proposed study and then to address them in future studies. The preliminary data suggest that likely mediators of RPE are both objective and subjective in nature. A key objective mediator of RPE is serum lactate level during exercise, which is a physiological marker of effort, and is disproportionately elevated in people with T2D vs. healthy controls. A key subjective mediator of RPE is self-efficacy, which influences the perception of exercise effort, and is disproportionately worse in people with T2D vs. healthy controls. To develop optimal physical activity interventions for people with T2D, the study investigators must understand whether RPE differences vary across the spectrum of exercise intensities (Aim 1), and the investigators must also determine the mediators of RPE across exercise intensities (Aim 2). Mediators of RPE in low-to-moderate intensity exercise are particularly important, because walking is a preferred physical activity for people with T2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| An Active Comparator exercise training intervention | Active Comparator | The Active Comparator Groupwill participate in an exercise training intervention to distinguish the relative roles of objective factors (lactate level) and subjective factors (self-efficacy) in mediating pre-post change in RPE during low, moderate, and vigorous exercise. |
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| A Placebo Attention Control | Placebo Comparator | The placebo attention control group will receive monthly diabetes education and phone calls phone calls to monitor their blood glucose levels. Participants will receive an accelerometer to wear for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Attention Control | Behavioral | The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rating of perceived exercise effort (RPE) during exercise (Borg RPE scale) | RPE was developed by Dr. Gunnar Borg and is a validated, self-reported measure of perceived effort during exercise. Possible scores range from 6 (no effort, resting) to 20 (maximal effort). Change = RPE post-intervention (week 20) - RPE baseline. | Baseline, week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum lactate during exercise | Serum lactate is measured by the University of Colorado clinical laboratory (Units = mg/dl). | Baseline, week 20 |
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Inclusion Criteria:
Sedentary men and women not participating in a regular exercise program (> 60 minutes of exercise per week)
If subject has diabetes,
Ages of 50-70 years
BMI between 25 and 35
Subjects can only be taking the following oral hypoglycemic drugs:
Persons with T2D only if they have total glycosylated hemoglobin levels (HbA1C) <8.0% (adequate control) on therapy.
Control subjects must have:
All women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (FSH) level.
Those who have quit smoking for at least 1 year will be accepted.
Absence of comorbid conditions that could affect exercise will be confirmed by history, physical examination and laboratory testing.
Exclusion Criteria:
Persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
Current use of insulin or other oral hypoglycemic medications.
Current smokers will be excluded since smoking can impair cardiovascular (CV) exercise performance
Persons will be excluded if they have:
Persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms.
Presence of:
Subjects with:
Subjects with:
Control subjects who have more than two immediate family members with type 2 diabetes.
Chronic obstructive pulmonary disease demonstrated by a ratio of
Persons weighing more than 300 pounds will be excluded as this exceeds the weight capacity of our Dual Energy X-ray Absorptiometry device
Participants with moderate cognitive impairment (Folstein Mini-Mental Status Examination (MMSE) score <24).
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| Name | Affiliation | Role |
|---|---|---|
| Amy Huebschmann, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Supervised Exercise Training | Other | The 20-week aerobic exercise training intervention provides supervised exercise training sessions 3 times weekly following the HERITAGE study training model that was feasible in prior studies with older, sedentary overweight adults (55%maximal oxygen uptake (VO2max) for 30 minutes per session at study entry with progressive titration to 70-80% VO2max for 50 minutes). |
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |