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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center GIM Small Grants |
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Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00785005 |
Given that sedentary behavior is associated with T2DM, the purpose of this study is to evaluate whether subjects with T2DM have a significant disincentive to performing exercise (due to greater perceived effort) . This study will prospectively compare the perceived exercise effort between T2DM and non-diabetic women while adjusting for potential confounders including baseline physical activity. This study will also assess whether perception of effort is associated with physiologic parameters related to exercise effort. Finally, we have 3 hypothesis-generating exploratory aims designed to screen for additional psychological and physiologic parameters that may increase perceived effort in those with T2DM.
Hypothesis 1: At the same absolute workload (e.g., 30 watts) and the same relative workloads, it is a greater effort for women with T2DM to exercise than for non-diabetic women.
Specific Aim 1: To determine differences in subjective perceived effort of bicycle exercise at low-to-moderate workloads in sedentary women with Type 2 Diabetes Mellitus (T2DM) vs. non-diabetic sedentary women.
Hypothesis 2: There will be a significant association between RPE and the physiologic measures related to work intensity (e.g., relative work intensity and tau2).
Specific Aim 2: In the same populations as SA1, to determine the strength of association during bicycle exercise between subjective perceived effort and physiologic measures related to work intensity.
Exploratory Aims:
Exploratory Aim 1: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and additional physiologic measures
Exploratory Aim 2: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and psychologic measures related to perception of effort.
Condition |
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Type 2 Diabetes |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Exercise-Related Perceived Rate of Exertion at Steady-State Workloads (ExPRESS) in Type 2 Diabetes Mellitus |
During the first visit, blood will be drawn for measurements of overall health (complete blood count and comprehensive metabolic panel), glucose and insulin levels, lipid levels, plasma FSH concentration, and HbA1C.
On two separate visits, blood samples will be drawn from a warmed IV site to measure muscle metabolites which change with exercise (e.g., glucose, calcium, lactate, H+, K+, and HCO3-) and may be associated with muscle pain or fatigue.
Estimated Enrollment: | 100 |
Study Start Date: | May 2008 |
Groups/Cohorts |
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Females with Type 2 Diabetes
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Females without Type 2 Diabetes
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Ages Eligible for Study: | 50 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Twenty-five sedentary post-menopausal women with uncomplicated T2DM (of duration ≤ 10 years) between the ages of 50-70 and twenty-five sedentary non-diabetic post-menopausal women between the ages of 50-70 will be recruited.
Inclusion Criteria:
Exclusion Criteria:
Contact: Leah Herlache, MS | 303-724-2255 | leah.herlache@uchsc.edu |
United States, Colorado | |
University of Colorado Denver | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Leah Herlache, MS 303-724-2255 leah.herlache@uchsc.edu | |
Principal Investigator: Amy Huebschmann, MD |
Principal Investigator: | Amy Huebschmann, MD | University of Colorado Denver |
Responsible Party: | University of Colorado Denver ( Amy Huebschmann, MD ) |
Study ID Numbers: | 07-0849 |
Study First Received: | November 3, 2008 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00785005 |
Health Authority: | United States: Institutional Review Board |
Diabetes Exercise Women Research |
Bike Type Control Healthy |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Metabolic disorder Glucose Metabolism Disorders |