Clinical trial NCT03203694: Effects of Walking and Heating on Vascular Function in Diabetic Patients
Official title: Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either a walking, a lower body heating, or no intervention.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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:

1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke;
2. renal or hepatic diseases;
3. active cancer;
4. autoimmune diseases;
5. immunosuppressant therapy;
6. excessive alcohol consumption (\>14 drinks/week for men; \>7 drinks/week for women);
7. current tobacco use;
8. pregnancy;
9. mobility limitations;
10. foot ulcers;
11. diabetic neuropathy
12. uncontrolled hypertension (\>=180 systolic / 100 diastolic mmHg)

Primary outcomes:
measure: Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)
timeFrame: Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.
measure: Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jaume Padilla, PhD
role: PRINCIPAL_INVESTIGATOR
References: