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

Primary Purpose

Spinal Cord Injuries, Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Hypoxia (IH)
SHAM
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Obesity, Insulin Resistance, Intermittent hypoxia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

SCI only:

  1. Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
  2. 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):

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

Sites / Locations

  • The Miami Project to Cure Paralysis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM

Control (CON) Intermittent Hypoxia then SHAM

Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia

Control (CON) SHAM then Intermittent Hypoxia

Arm Description

This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.

This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.

This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.

This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
November 18, 2016
Last Updated
November 23, 2020
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02973438
Brief Title
Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI
Official Title
Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Obesity, Insulin Resistance
Keywords
Spinal Cord Injuries, Obesity, Insulin Resistance, Intermittent hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
Arm Type
Experimental
Arm Description
This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Arm Title
Control (CON) Intermittent Hypoxia then SHAM
Arm Type
Experimental
Arm Description
This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Arm Title
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
Arm Type
Experimental
Arm Description
This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Arm Title
Control (CON) SHAM then Intermittent Hypoxia
Arm Type
Experimental
Arm Description
This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Intervention Type
Device
Intervention Name(s)
Intermittent Hypoxia (IH)
Other Intervention Name(s)
Hypoxico
Intervention Description
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%.
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
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 Outcome Measure Information:
Title
Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
Description
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.
Time Frame
Baseline, day 5
Secondary Outcome Measure Information:
Title
Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test
Description
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).
Time Frame
Baseline, day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nash, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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