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The purpose of the present study is to determine the effects of increased walking and lower body heating on leg vascular function in patients with type 2 diabetes (T2D).
The notion that habitual aerobic exercise increases insulin-induced vasodilation is largely founded on rodent studies, hence the urgent need for human studies, especially in patients with type 2 diabetes (T2D). For example, it remains unknown if increased walking, the most common form of physical activity, enhances skeletal muscle vasodilator actions of insulin in T2D. In addition, the molecular mechanisms by which exercise improves vasoreactivity to insulin have not been examined in humans. The investigators propose that in T2D patients who are sedentary (i.e., the vast majority), increased leg blood flow with walking or local heating signifies a vital strategy to correct vascular insulin resistance. This study will establish whether increased physical activity and associated hemodynamic forces (e.g., shear stress) are a direct form of vascular medicine in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking: Intervention arm in diabetics | Experimental | The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. |
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| Walking: No intervention in diabetics | Experimental | Subjects will be instructed to continue their usual lifestyle for 8 weeks. |
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| Walking: Healthy cohort as reference controls | Other | Subjects will be studied at one time only. |
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| Lower body heating: Intervention arm in healthy subjects | Experimental | This intervention consists of 60 minutes of lower body heating (40-42 degree C). |
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| Lower body heating: Intervention arm in diabetics | Experimental | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking: Intervention arm in diabetics | Behavioral | The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60) | Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed at baseline (t0) and after 60 minutes of insulin stimulation (t60). | Percent change from baseline leg blood flow during 60 minutes of insulin stimulation. |
| Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60). | Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed pre-intervention and post-intervention at baseline (t0) and after 60 minutes of insulin stimulation (t60). Outcome measure indicates whether percent change in insulin-stimulated blood flow increased or decreased following intervention. Interventions that show an increase demonstrate an improvement in insulin-stimulated blood flow. | Change from baseline insulin-stimulated leg blood flow following 1 heating session, 7 days of heating intervention, or 8 weeks of walking intervention/no intervention. |
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Inclusion Criteria:
Patients with type 2 diabetes who are overweight and obese (BMI 25-50 kg/m2), 35 to 65 years of age, and sedentary (<60 minutes structured exercise/week). Healthy volunteers without type 2 diabetes: 18 to 65 years of age.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaume Padilla, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Walking: Intervention Arm in Diabetics | The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. Walking: Intervention arm in diabetics: The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2020 | Sep 27, 2023 |
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Participants will be assigned to either a walking, a lower body heating, or no intervention.
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| Lower body heating: Healthy cohort as reference controls | Other | Subjects will be studied at one time only. |
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| Walking: No intervention in diabetics | Other | Subjects will be instructed to continue their usual lifestyle for 8 weeks. |
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| Walking: Healthy cohort as reference controls | Other | Subjects will be studied at one time only. |
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| Lower body heating: Intervention arm in healthy subjects | Behavioral | This intervention consists of 60 minutes of lower body heating (40-42 degree C). |
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| Lower body heating: Intervention arm in diabetics | Behavioral | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. |
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| Lower body heating: Healthy cohort as reference controls | Other | Subjects will be studied at one time only. |
|
| Walking: No Intervention in Diabetics |
Subjects will be instructed to continue their usual lifestyle for 8 weeks. Walking: No intervention in diabetics: Subjects will be instructed to continue their usual lifestyle for 8 weeks. |
| FG002 | Walking: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. Walking: Healthy cohort as reference controls: Subjects will be studied at one time only. |
| FG003 | Lower Body Heating: Intervention Arm in Healthy Subjects | This intervention consists of 60 minutes of lower body heating (40-42 degree C). Lower body heating: Intervention arm in healthy subjects: This intervention consists of 60 minutes of lower body heating (40-42 degree C). |
| FG004 | Lower Body Heating: Intervention Arm in Diabetics | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. Lower body heating: Intervention arm in diabetics: This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. |
| FG005 | Lower Body Heating: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. Lower body heating: Healthy cohort as reference controls: Subjects will be studied at one time only. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Walking: Intervention Arm in Diabetics | The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. Walking: Intervention arm in diabetics: The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. |
| BG001 | Walking: No Intervention in Diabetics | Subjects will be instructed to continue their usual lifestyle for 8 weeks. Walking: No intervention in diabetics: Subjects will be instructed to continue their usual lifestyle for 8 weeks. |
| BG002 | Walking: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. Walking: Healthy cohort as reference controls: Subjects will be studied at one time only. |
| BG003 | Lower Body Heating: Intervention Arm in Healthy Subjects | This intervention consists of 60 minutes of lower body heating (40-42 degree C). Lower body heating: Intervention arm in healthy subjects: This intervention consists of 60 minutes of lower body heating (40-42 degree C). |
| BG004 | Lower Body Heating: Intervention Arm in Diabetics | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. Lower body heating: Intervention arm in diabetics: This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. |
| BG005 | Lower Body Heating: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. Lower body heating: Healthy cohort as reference controls: Subjects will be studied at one time only. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Drop out subjects are not included in the BMI calculation. | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60) | Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed at baseline (t0) and after 60 minutes of insulin stimulation (t60). | Outcomes data from participants who were assigned to an intervention arm are reported under Outcome 2 (change from baseline to post-intervention). | Posted | Mean | Standard Error | percentage change | Percent change from baseline leg blood flow during 60 minutes of insulin stimulation. |
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| Primary | Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60). | Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed pre-intervention and post-intervention at baseline (t0) and after 60 minutes of insulin stimulation (t60). Outcome measure indicates whether percent change in insulin-stimulated blood flow increased or decreased following intervention. Interventions that show an increase demonstrate an improvement in insulin-stimulated blood flow. | Outcomes data from participants who were not assigned a treatment arm are reported under Outcome 1 (Percent change in insulin-stimulated blood flow). | Posted | Mean | Standard Error | percent change | Change from baseline insulin-stimulated leg blood flow following 1 heating session, 7 days of heating intervention, or 8 weeks of walking intervention/no intervention. |
|
8 weeks: (Walking: Intervention arm in diabetics; Walking: No intervention in diabetics) 7 days: (Lower body heating: Intervention arm in healthy subjects; Lower body heating: Intervention arm in diabetics) 1 day (1 session): (Walking: Healthy cohort as reference controls; Lower body heating: Healthy cohort as reference controls)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Walking: Intervention Arm in Diabetics | The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. | 0 | 13 | 0 | 13 | 1 | 13 |
| EG001 | Walking: No Intervention in Diabetics | Subjects will be instructed to continue their usual lifestyle for 8 weeks. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Walking: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Lower Body Heating: Intervention Arm in Healthy Subjects | This intervention consists of 60 minutes of lower body heating (40-42 degree C). | 0 | 18 | 0 | 18 | 1 | 18 |
| EG004 | Lower Body Heating: Intervention Arm in Diabetics | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG005 | Lower Body Heating: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic response to contrast agent | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Experience of allergic skin reaction to Definity (Perflutren) contrast agent. |
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| Vasovegal Reaction | Vascular disorders | Non-systematic Assessment | Vaso-vegal reaction in response to IV placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaume Padilla | University of Missouri | (573) 882-7056 | padillaja@missouri.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2020 | Apr 1, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Lower body heating | Mar 10, 2021 | Sep 27, 2023 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Lower body heating: Healthy cohort as reference controls | Apr 11, 2018 | Sep 27, 2023 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Walking | Apr 10, 2019 | Sep 27, 2023 | ICF_004.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects will be studied at one time only. |
| OG003 | Lower Body Heating: Intervention Arm in Healthy Subjects | This intervention consists of 60 minutes of lower body heating (40-42 degree C). |
| OG004 | Lower Body Heating: Intervention Arm in Diabetics | This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. |
| OG005 | Lower Body Heating: Healthy Cohort as Reference Controls | Subjects will be studied at one time only. |
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