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NCT Number: NCT06882460

Diet and Exercise Solutions to Postprandial Hypotension

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dodd Rehabilitation Hospital

Columbus, Ohio, 43210, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic load

Other

Low glycemic load diet

Electrical stimulation exercise

Other

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

High Glycemic Load Diet

Other

High glycemic load diet

Primary outcomes

  1. 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

Secondary outcomes

  1. Magnitude of systolic blood pressure decrease (at-home)

    Time frame: 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

  2. Postprandial glucose (in-lab)

    Time frame: 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.

  3. Postprandial insulin (in-lab)

    Time frame: 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.

  4. Postprandial glucose (at-home)

    Time frame: 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

  5. Blood flow (in-lab)

    Time frame: 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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