NCT06882460

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
May 2025Dec 2026

First Submitted

Initial submission to the registry

December 12, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

December 12, 2024

Last Update Submit

April 22, 2026

Conditions

Spinal Cord Injuries

Keywords

postprandial hypotensionelectrical stimulationlow-glycemic diet

Outcome Measures

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

    Visit 2-4, Day 1

Secondary Outcomes (5)

  • Magnitude of systolic blood pressure decrease (at-home)

    Visits 2-4, Days 1-3

  • Postprandial glucose (in-lab)

    Visits 2-4, Day 1

  • Postprandial insulin (in-lab)

    Visits 2-4, Day 1

  • Postprandial glucose (at-home)

    Visits 2-4, Day 1-3

  • Blood flow (in-lab)

    Visits 2-4, Day 1

Study Arms (3)

High glycemic load

PLACEBO COMPARATOR
Other: High glycemic load diet

Low glycemic load

EXPERIMENTAL
Other: Low glycemic load

Electrical Stimulation

EXPERIMENTAL
Other: Electrical stimulation exerciseOther: High glycemic load diet

Interventions

Low glycemic loadOTHER

Low glycemic load diet

Low glycemic load
Electrical stimulation exerciseOTHER

Lower-body electrical stimulation exercise for 1-h after eating

Electrical Stimulation
High glycemic load dietOTHER

High glycemic load diet

Electrical StimulationHigh glycemic load

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
  • AIS A or B
  • \>1-year post-injury

You may not qualify if:

  • 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
  • Use of abdominal binder or anti-hypotensive drugs
  • Fitted with pacemaker or defibrillator
  • Currently receiving electrical stimulation training or in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dodd Rehabilitation Hospital

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Matthew Farrow, PhD

CONTACT

614-293-2812Matthew.Farrow@osumc.edu

Ceren Yarar-Fisher, PhD

CONTACT

Ceren.Yarar-Fisher@osumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2024

First Posted

March 18, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

US(1)