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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Insulin Resistance; Obesity
• Interventions: Device: Intermittent Hypoxia (IH); Device: SHAM

• Registration Number: NCT02973438
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-25
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Results First Submitted: 2020-02-26
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Results First Posted: 2020-12-17
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control (CON) Intermittent Hypoxia then SHAM	Intermittent Hypoxia (IH)	This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Control (CON) Intermittent Hypoxia then SHAM	SHAM	This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia	SHAM	This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM	Intermittent Hypoxia (IH)	This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM	SHAM	This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
Control (CON) SHAM then Intermittent Hypoxia	Intermittent Hypoxia (IH)	This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia	Intermittent Hypoxia (IH)	This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
Control (CON) SHAM then Intermittent Hypoxia	SHAM	This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

The Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States