Effects of Walking and Heating on Vascular Function in Diabetic Patients

NCT03203694 | Completed Results DMC

• 1 other identifier: 2008181
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (6)

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.

Behavioral: Walking: Intervention arm in diabetics

Walking: No intervention in diabetics

EXPERIMENTAL

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

Other: Walking: No intervention in diabetics

Walking: Healthy cohort as reference controls

OTHER

Subjects will be studied at one time only.

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).

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.

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.

Other: Lower body heating: Healthy cohort as reference controls

Interventions

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: Intervention arm in diabetics

Walking: No intervention in diabetics OTHER

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

Walking: No intervention in diabetics

Walking: Healthy cohort as reference controls OTHER

Subjects will be studied at one time only.

Walking: Healthy cohort as reference controls

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 healthy subjects

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: Intervention arm in diabetics

Lower body heating: Healthy cohort as reference controls OTHER

Subjects will be studied at one time only.

Lower body heating: Healthy cohort as reference controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jaume Padilla
• Organization: University of Missouri

padillaja@missouri.edu

(573) 882-7056

Study Officials

• Jaume Padilla, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be assigned to either a walking, a lower body heating, or no intervention.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 29, 2017
• Study Start: December 4, 2017
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)