Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes

NCT02513641 | Completed Results

• 1 other identifier: PBRC 2015-018
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if 2 weeks of nightly exposure (7-12 hours per night) to moderate hypoxia (\~2,400 meters or 7,500 feet) improves glucose metabolism in people with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Insulin sensitivity was determined using an oral glucose tolerance test. Insulin sensitivity was estimated using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index (unitless): WBISI = 10,000 / \[square root of (Glu0 x Ins0) x (mean glucose x mean insulin during an oral glucose tolerance test)\] where Glu0 and Ins0 denote baseline glucose and insulin concentrations.

  Baseline and Post-Moderate Hypoxia (14 days)

Secondary Outcomes (4)

• Insulin Secretion

  Baseline and Post-Moderate Hypoxia (14 days)

• Beta-cell Function

  Baseline and Post-Moderate Hypoxia (14 days)

• 2-hour Glucose Area-under-the-curve

  0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)

• 2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test

  0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)

Study Arms (1)

Moderate Hypoxia

EXPERIMENTAL

2-weeks of nightly exposure (7-12 hrs per night) to moderate hypoxia (\~2,400 meters) using the Hypoxico Altitude Training Systems device.

Device: Hypoxico Altitude Training Systems

Interventions

Hypoxico Altitude Training Systems DEVICE

Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.

Moderate Hypoxia

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20-65 yrs
• Body mass index (BMI) \< 55 kg/m2
• Body weight 450 lbs or less (to accommodate body composition assessment)
• Have either been diagnosed with type 2 diabetes, or fasting blood glucose between 125 and 200 mg/dL, or have a hemoglobin A1c ≥ 6.5%
• Non-smokers
• Weight stable over the previous 3 months (\<3 kg fluctuation)
• Known diagnosis of sleep apnea and ownership of a continuous positive airway pressure (C-PAP) device that must be worn throughout the nights spent in the tent
• If no known presence of sleep apnea, be willing to spend one night in a sleep laboratory (Louisiana Sleep Foundation) to assess presence of sleep apnea

You may not qualify if:

• Diagnosed with T2DM ≥ 15 years ago
• Pregnant Women
• Current insulin treatment
• Treatment with sulfonylureas or glitinides
• Treatment with a GLP-1 agonist
• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive heart failure
• Prior severe cardiovascular events such as stroke or myocardial infarction
• If treated for T2DM with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
• Previously known diagnosis of sleep apnea without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned CPAP device during the nights spent in the tent
• Presence of sleep apnea following a positive home sleep test (HST), or have unsafe oxyhemoglobin saturation levels (less than 78%) during a one night sleep monitoring assessment conducted at the Louisiana Sleep Foundation without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned C-PAP device during the nights spent in the tent
• History of high altitude sickness
• History of altitude sickness
• Does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Eric Ravussin
• Organization: Pennington Biomedical Research Center

eric.ravussin@pbrc.edu

225-763-3186

Study Officials

• Eric Ravussin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 31, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2020
• Last Updated: October 12, 2020
• Results First Posted: October 30, 2019

Record last verified: 2020-09

Locations

US (2)