Diet and Exercise Solutions to Postprandial Hypotension

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT06882460
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Study Start: 2025-05-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Magnitude of systolic blood pressure decrease (in-lab)	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

Secondary Outcome Measures

Name	Time	Method
Magnitude of systolic blood pressure decrease (at-home)	Visits 2-4, Days 1-3	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
Postprandial glucose (in-lab)	Visits 2-4, Day 1	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.
Postprandial insulin (in-lab)	Visits 2-4, Day 1	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.
Postprandial glucose (at-home)	Visits 2-4, Day 1-3	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
Blood flow (in-lab)	Visits 2-4, Day 1	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.

Trial Locations

Locations (1)

Dodd Rehabilitation Hospital; 🇺🇸 Columbus, Ohio, United States