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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973438
• Other study ID #: 20160818
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Insulin Resistance
• Obesity
• Overweight
• Spinal Cord Injuries

Intervention

Device:
• Intermittent Hypoxia (IH)
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%.
• SHAM
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).

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, day 5
Secondary	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).	Baseline, day 5