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Completed

NCT Number: NCT02973438

Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI

The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control).

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Key information

Conditions

Spinal Cord Injuries Body Weight Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

SCI only:

  • Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
  • ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).

SCI and non injured control:

Resting SaO2 ≥ 95%

Exclusion criteria

(SCI and non injured control):

  • Currently hospitalized
  • Resting heart rate ≥120 BPM
  • Resting systolic blood pressure >180 mm Hg
  • Resting diastolic Blood Pressure >100 mmHg
  • Self-reported history of unstable angina or myocardial infarction within the previous month
  • Previous cardiac surgery or condition that evidences ischemic heart disease
  • Cardiopulmonary complication such as COPD
  • Pregnancy determined by urine testing in sexually active females.

Treatment and study plan

Intermittent Hypoxia (IH)

Device

Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.

Other names: Hypoxico

SHAM

Device

Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).

Primary outcomes

  1. Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)

    Time frame: Baseline, day 5

    Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of > 1.8 were considered insulin resistant.

Secondary outcomes

  1. Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test

    Time frame: Baseline, day 5

    Change in exercise substrate partitioning as measured via endurance-maximal oxygen consumption (VO2peak test) and will be reported as change in carbohydrate oxidation (% of total energy expenditure).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2016
Registry last updated
Dec 17, 2020

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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