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Lower body heating: Intervention arm in diabetics for Type 2 Diabetes
N/A
Waitlist Available
Led By Jaume Padilla, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial will help determine if increased walking and lower body heating can improve leg vascular function in patients with type 2 diabetes.
Eligible Conditions
- Type 2 Diabetes
- Obesity
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)
Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).
Trial Design
6Treatment groups
Experimental Treatment
Group I: Walking: No intervention in diabeticsExperimental Treatment1 Intervention
Subjects will be instructed to continue their usual lifestyle for 8 weeks.
Group II: Walking: Intervention arm in diabeticsExperimental Treatment1 Intervention
The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.
Group III: Walking: Healthy cohort as reference controlsExperimental Treatment1 Intervention
Subjects will be studied at one time only.
Group IV: Lower body heating: Intervention arm in healthy subjectsExperimental Treatment1 Intervention
This intervention consists of 60 minutes of lower body heating (40-42 degree C).
Group V: Lower body heating: Intervention arm in diabeticsExperimental Treatment1 Intervention
This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.
Group VI: Lower body heating: Healthy cohort as reference controlsExperimental Treatment1 Intervention
Subjects will be studied at one time only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Walking: Intervention arm in diabetics
2017
N/A
~100
Lower body heating: Intervention arm in diabetics
2017
N/A
~100
Lower body heating: Intervention arm in healthy subjects
2017
N/A
~100
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,015 Total Patients Enrolled
Jaume Padilla, PhDPrincipal Investigator - University of Missouri-Columbia
University of Missouri-Columbia
1 Previous Clinical Trials
8 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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