Spinal Cord InjuriesNCT06882460
Diet and Exercise Solutions to Postprandial Hypotension
A study testing Low glycemic load, Electrical stimulation exercise and High glycemic load diet in people with Spinal Cord Injuries, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Low glycemic load, Electrical stimulation exercise and High glycemic load diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
- AIS A or B
- >1-year post-injury
Who cannot join
- Currently pregnant of breast-feeding
- Type 1 or 2 diabetes
- Previous gut augmentation bariatric surgery
- Neurological impairment other than SCI
- History of uncontrolled autonomic dysreflexia
- History of bone fractures
Show all 9Show fewer
- Use of abdominal binder or anti-hypotensive drugs
- Fitted with pacemaker or defibrillator
- Currently receiving electrical stimulation training or in the previous year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ceren Yarar-Fisher, PhD contact
United States1 site, 1 recruiting
- Recruiting
Dodd Rehabilitation Hospital
Columbus, Ohio, 43210
Matthew Farrow, Matthew.Farrow@osumc.edu
About this study
Official title: Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Low glycemic load, Electrical stimulation exercise, High glycemic load diet
- Keywords
- postprandial hypotension, electrical stimulation, low-glycemic diet
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic loadOther
Low glycemic load diet
Electrical stimulation exerciseOther
Lower-body electrical stimulation exercise for 1-h after eating
High glycemic load dietOther
High glycemic load diet
| Study group | Role | What they receive |
|---|---|---|
| High glycemic load | Placebo comparator | Not described Receives: Other: High glycemic load diet |
| Low glycemic load | Experimental | Not described Receives: Other: Low glycemic load |
| Electrical Stimulation | Experimental | Not described Receives: Other: Electrical stimulation exercise; Other: High glycemic load diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 2-4, Day 1
Secondary outcomes (5)
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
Measured: Visits 2-4, Days 1-3
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.
Measured: Visits 2-4, Day 1
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.
Measured: Visits 2-4, Day 1
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
Measured: Visits 2-4, Day 1-3
Blood flow (in-lab)
Blood flow at the radial, brachial, popliteal and superior mesenteric arteries will be obtained using Doppler imaging at regular intervals after eating breakfast (3-h) and lunch (2-h) under laboratory controlled conditions.
Measured: Visits 2-4, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start15 May 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Yarar-Fisher, The Craig H. Neilsen Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882460
- Sponsor's protocol ID
- 2024H0147
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06882460
- Acronym / sponsor ID
- 2024H0147
- Conditions
- Spinal Cord Injuries
- Keywords
- postprandial hypotension, electrical stimulation, low-glycemic diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High glycemic load | Placebo comparator | Other: High glycemic load diet |
| Low glycemic load | Experimental | Other: Low glycemic load |
| Electrical Stimulation | Experimental | Other: Electrical stimulation exercise, Other: High glycemic load diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
- AIS A or B
- >1-year post-injury
Key exclusion criteria (9 listed)
- Currently pregnant of breast-feeding
- Type 1 or 2 diabetes
- Previous gut augmentation bariatric surgery
- Neurological impairment other than SCI
- History of uncontrolled autonomic dysreflexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic loadLow glycemic load diet | Other | Low glycemic load |
| Electrical stimulation exerciseLower-body electrical stimulation exercise for 1-h after eating | Other | Electrical Stimulation |
| High glycemic load dietHigh glycemic load diet | Other | Electrical Stimulation, High glycemic load |
Primary outcome
Magnitude of systolic blood pressure decrease (in-lab)
Time frame: Visit 2-4, Day 1
Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast and lunch under laboratory-controlled conditions
5 secondary outcomes
Magnitude of systolic blood pressure decrease (at-home)
Time frame: Visits 2-4, Days 1-3
Postprandial glucose (in-lab)
Time frame: Visits 2-4, Day 1
Postprandial insulin (in-lab)
Time frame: Visits 2-4, Day 1
Postprandial glucose (at-home)
Time frame: Visits 2-4, Day 1-3
Blood flow (in-lab)
Time frame: Visits 2-4, Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Related trials for Spinal Cord Injuries
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Recruiting
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Tetraplegia/Tetraparesis
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ceren Yarar-Fisher, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic load, Electrical stimulation exercise and High glycemic load diet in people with Spinal Cord Injuries, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Farrow, PhD (614-293-2812, Matthew.Farrow@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of systolic blood pressure decrease (in-lab) (time frame: Visit 2-4, Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.