Trial Outcomes & Findings for Effects of Walking and Heating on Vascular Function in Diabetic Patients (NCT NCT03203694)

NCT ID: NCT03203694

Last Updated: 2024-04-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

99 participants

Primary outcome timeframe

Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.

Results posted on

2024-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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).	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.	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.
Overall Study STARTED	13	13	15	18	20	20
Overall Study COMPLETED	11	13	15	18	20	20
Overall Study NOT COMPLETED	2	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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).	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.	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.
Overall Study Withdrawal by Subject	2	0	0	0	0	0

Baseline Characteristics

Drop out subjects are not included in the BMI calculation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Walking: Intervention Arm in Diabetics n=13 Participants 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.	Walking: No Intervention in Diabetics n=13 Participants 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.	Walking: Healthy Cohort as Reference Controls n=15 Participants Subjects will be studied at one time only. Walking: Healthy cohort as reference controls: Subjects will be studied at one time only.	Lower Body Heating: Intervention Arm in Healthy Subjects n=18 Participants 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).	Lower Body Heating: Intervention Arm in Diabetics n=20 Participants 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.	Lower Body Heating: Healthy Cohort as Reference Controls n=20 Participants Subjects will be studied at one time only. Lower body heating: Healthy cohort as reference controls: Subjects will be studied at one time only.	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants	13 Participants n=13 Participants	15 Participants n=15 Participants	18 Participants n=18 Participants	20 Participants n=20 Participants	20 Participants n=20 Participants	99 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Sex: Female, Male Female	6 Participants n=13 Participants	6 Participants n=13 Participants	10 Participants n=15 Participants	8 Participants n=18 Participants	12 Participants n=20 Participants	12 Participants n=20 Participants	54 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=13 Participants	7 Participants n=13 Participants	5 Participants n=15 Participants	10 Participants n=18 Participants	8 Participants n=20 Participants	8 Participants n=20 Participants	45 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=13 Participants	0 Participants n=13 Participants	3 Participants n=15 Participants	4 Participants n=18 Participants	0 Participants n=20 Participants	4 Participants n=20 Participants	12 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=13 Participants	13 Participants n=13 Participants	12 Participants n=15 Participants	14 Participants n=18 Participants	20 Participants n=20 Participants	16 Participants n=20 Participants	87 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=13 Participants	1 Participants n=13 Participants	0 Participants n=15 Participants	1 Participants n=18 Participants	5 Participants n=20 Participants	0 Participants n=20 Participants	7 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=13 Participants	12 Participants n=13 Participants	15 Participants n=15 Participants	17 Participants n=18 Participants	15 Participants n=20 Participants	20 Participants n=20 Participants	92 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=99 Participants
Region of Enrollment United States	13 Participants n=13 Participants	13 Participants n=13 Participants	15 Participants n=15 Participants	18 Participants n=18 Participants	20 Participants n=20 Participants	20 Participants n=20 Participants	99 Participants n=99 Participants
Body Mass Index (BMI)	36.9 kg/m^2 STANDARD_DEVIATION 1.6 • n=11 Participants • Drop out subjects are not included in the BMI calculation.	36.2 kg/m^2 STANDARD_DEVIATION 1.7 • n=13 Participants • Drop out subjects are not included in the BMI calculation.	23.5 kg/m^2 STANDARD_DEVIATION 2.3 • n=15 Participants • Drop out subjects are not included in the BMI calculation.	25.1 kg/m^2 STANDARD_DEVIATION 4.2 • n=18 Participants • Drop out subjects are not included in the BMI calculation.	35.9 kg/m^2 STANDARD_DEVIATION 1.2 • n=20 Participants • Drop out subjects are not included in the BMI calculation.	23.7 kg/m^2 STANDARD_DEVIATION 2.2 • n=20 Participants • Drop out subjects are not included in the BMI calculation.	29.6 kg/m^2 STANDARD_DEVIATION 2.2 • n=97 Participants • Drop out subjects are not included in the BMI calculation.

PRIMARY outcome

Timeframe: Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.

Population: Outcomes data from participants who were assigned to an intervention arm are reported under Outcome 2 (change from baseline to post-intervention).

Outcome measures

Outcome measures
Measure	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: No Intervention in Diabetics Subjects will be instructed to continue their usual lifestyle for 8 weeks.	Walking: Healthy Cohort as Reference Controls n=15 Participants Subjects will be studied at one time only.	Lower Body Heating: Intervention Arm in Healthy Subjects This intervention consists of 60 minutes of lower body heating (40-42 degree C).	Experimental: 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: Healthy Cohort as Reference Controls n=20 Participants Subjects will be studied at one time only.
Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)	—	—	133.6 percentage change Standard Error 48.7	—	—	8.92 percentage change Standard Error 2.26

PRIMARY outcome

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.

Population: Outcomes data from participants who were not assigned a treatment arm are reported under Outcome 1 (Percent change in insulin-stimulated blood flow).

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.