Diet and Exercise Solutions to Postprandial Hypotension
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOhio State University
About this trial
The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
AIS A or B
>1-year post-injury
Disqualifiers
Currently pregnant of breast-feeding
Type 1 or 2 diabetes
Previous gut augmentation bariatric surgery
Neurological impairment other than SCI
Trial design
Design model
Crossover
Treatments tested in this trial
Low glycemic load
Other interventionLow glycemic load diet
Electrical stimulation exercise
Other interventionLower-body electrical stimulation exercise for 1-h after eating
High glycemic load diet
Other interventionHigh glycemic load diet
Treatment groups
13 Participants
are divided into 3 treatment groupsGroup A: High glycemic loadPlacebo comparator 1 intervention
Group B: Low glycemic loadExperimental treatment 1 intervention
Group C: Electrical StimulationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Magnitude of systolic blood pressure decrease (in-lab)
Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast and lunch under laboratory-controlled conditions
Time frame
Visit 2-4, Day 1Secondary outcomes
1
Magnitude of systolic blood pressure decrease (at-home)
Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast, lunch, and dinner for 3-days during at-home testing
Time frame
Visits 2-4, Days 1-32
Postprandial glucose (in-lab)
Blood samples will be obtained from an intravenous catheter at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.
Time frame
Visits 2-4, Day 13
Postprandial insulin (in-lab)
Blood samples will be obtained from an intravenous catheter at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.
Time frame
Visits 2-4, Day 14
Postprandial glucose (at-home)
A continuous glucose monitor will be used to measure glucose for 2-h after breakfast, lunch, and dinner for 3-days during at-home testing
Time frame
Visits 2-4, Day 1-3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
The Craig H. Neilsen Foundation
Sponsor institution
Source ClinicalTrials.gov