Type 2 Diabetes MellitusNCT03203694
Effects of Walking and Heating on Vascular Function in Diabetic Patients
A study testing Walking: Intervention arm in diabetics, Lower body heating: Intervention arm in healthy subjects and Lower body heating: Intervention arm in diabetics in people with Type 2 Diabetes Mellitus and Obesity, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- Walking: Intervention arm in diabetics, Lower body heating: Intervention arm in healthy subjects and Lower body heating: Intervention arm in diabetics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke;
- renal or hepatic diseases;
- active cancer;
- autoimmune diseases;
- immunosuppressant therapy;
- excessive alcohol consumption (>14 drinks/week for men; >7 drinks/week for women);
Show all 12Show fewer
- current tobacco use;
- pregnancy;
- mobility limitations;
- foot ulcers;
- diabetic neuropathy
- uncontrolled hypertension (>=180 systolic / 100 diastolic mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes
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).
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Walking: Intervention arm in diabetics, Walking: No intervention in diabetics, Walking: Healthy cohort as reference controls, Lower body heating: Intervention arm in healthy subjects, Lower body heating: Intervention arm in diabetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking: Intervention arm in diabeticsBehavioural
The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.
Walking: No intervention in diabeticsOther
Subjects will be instructed to continue their usual lifestyle for 8 weeks.
Walking: Healthy cohort as reference controlsOther
Subjects will be studied at one time only.
Lower body heating: Intervention arm in healthy subjectsBehavioural
This intervention consists of 60 minutes of lower body heating (40-42 degree C).
Lower body heating: Intervention arm in diabeticsBehavioural
This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.
Lower body heating: Healthy cohort as reference controlsOther
Subjects will be studied at one time only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Walking: Intervention arm in diabetics |
| Walking: No intervention in diabetics | Experimental | Subjects will be instructed to continue their usual lifestyle for 8 weeks. Receives: Other: Walking: No intervention in diabetics |
| Walking: Healthy cohort as reference controls | Other | Subjects will be studied at one time only. Receives: Other: Walking: Healthy cohort as reference controls |
| Lower body heating: Intervention arm in healthy subjects | Experimental | This intervention consists of 60 minutes of lower body heating (40-42 degree C). Receives: Behavioral: Lower body heating: Intervention arm in healthy subjects |
| 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. Receives: Behavioral: Lower body heating: Intervention arm in diabetics |
| Lower body heating: Healthy cohort as reference controls | Other | Subjects will be studied at one time only. Receives: Other: Lower body heating: Healthy cohort as reference controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start4 Dec 2017
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either a walking, a lower body heating, or no intervention.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaume Padilla, University of Missouri-Columbia
- Investigators
- Jaume Padilla, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203694
- Sponsor's protocol ID
- 2008181
- Status last verified
- Apr 2024
- First submitted
- 23 Jun 2017
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03203694
- Acronym / sponsor ID
- 2008181
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants will be assigned to either a walking, a lower body heating, or no intervention.
| Arm | Type | Receives |
|---|---|---|
| Walking: Intervention arm in diabetics | Experimental | Behavioral: Walking: Intervention arm in diabeticsThe walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. |
| Walking: No intervention in diabetics | Experimental | Other: Walking: No intervention in diabeticsSubjects will be instructed to continue their usual lifestyle for 8 weeks. |
| Walking: Healthy cohort as reference controls | Other | Other: Walking: Healthy cohort as reference controlsSubjects will be studied at one time only. |
| Lower body heating: Intervention arm in healthy subjects | Experimental | Behavioral: Lower body heating: Intervention arm in healthy subjectsThis intervention consists of 60 minutes of lower body heating (40-42 degree C). |
| Lower body heating: Intervention arm in diabetics | Experimental | Behavioral: Lower body heating: Intervention arm in diabeticsThis intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. |
| Lower body heating: Healthy cohort as reference controls | Other | Other: Lower body heating: Healthy cohort as reference controlsSubjects will be studied at one time only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke;
- renal or hepatic diseases;
- active cancer;
- autoimmune diseases;
- immunosuppressant therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking: Intervention arm in diabeticsThe walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks. | Behavioural | Walking: Intervention arm in diabetics |
| Walking: No intervention in diabeticsSubjects will be instructed to continue their usual lifestyle for 8 weeks. | Other | Walking: No intervention in diabetics |
| Walking: Healthy cohort as reference controlsSubjects will be studied at one time only. | Other | Walking: Healthy cohort as reference controls |
| Lower body heating: Intervention arm in healthy subjectsThis intervention consists of 60 minutes of lower body heating (40-42 degree C). | Behavioural | Lower body heating: Intervention arm in healthy subjects |
| Lower body heating: Intervention arm in diabeticsThis intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days. | Behavioural | Lower body heating: Intervention arm in diabetics |
| Lower body heating: Healthy cohort as reference controlsSubjects will be studied at one time only. | Other | Lower body heating: Healthy cohort as reference controls |
Primary outcome
Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)
Time frame: Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.
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).
Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaume Padilla, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking: Intervention arm in diabetics, Lower body heating: Intervention arm in healthy subjects and Lower body heating: Intervention arm in diabetics in people with Type 2 Diabetes Mellitus and Obesity, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60) (time frame: Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.