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Completed

NCT Number: NCT03203694

Effects of Walking and Heating on Vascular Function in Diabetic Patients

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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);
  • current tobacco use;
  • pregnancy;
  • mobility limitations;
  • foot ulcers;
  • diabetic neuropathy
  • uncontrolled hypertension (>=180 systolic / 100 diastolic mmHg)

Treatment and study plan

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.

Walking: No intervention in diabetics

Other

Subjects will be instructed to continue their usual lifestyle for 8 weeks.

Walking: Healthy cohort as reference controls

Other

Subjects will be studied at one time only.

Lower body heating: Intervention arm in healthy subjects

Behavioral

This intervention consists of 60 minutes of lower body heating (40-42 degree C).

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.

Lower body heating: Healthy cohort as reference controls

Other

Subjects will be studied at one time only.

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2017
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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