Diet and Exercise Solutions to Postprandial Hypotension

The Ohio State University

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Electrical stimulation exercise; Other: High glycemic load diet; Other: Low glycemic load

Study type: Interventional

Funder types: Other

Identifiers

NCT06882460

2024H0147

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 3 patient groups, including a placebo group

High glycemic load

Placebo Comparator group

Treatment:

Other: High glycemic load diet

Low glycemic load

Experimental group

Treatment:

Other: Low glycemic load

Electrical Stimulation

Experimental group

Treatment:

Other: High glycemic load diet

Other: Electrical stimulation exercise