Skip to main content
OpenTrials
Completed

NCT Number: NCT02513641

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Loading trial locations.

About this study

Exposure to hypoxia has been advocated as a possible therapeutic aid against obesity. Indeed, our laboratory has provided the first evidence that intermittent, nightly exposure to moderate hypoxia is beneficial in improving insulin sensitivity in healthy obese patients and, therefore, lowers the risk of developing type 2 diabetes. Benefits included reduced fasting glucose levels and improved whole-body (skeletal muscle) and hepatic insulin sensitivity. Whether such intermittent hypoxia improves glucose metabolism in people with type 2 diabetes is unknown.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • Diagnosed with T2DM ≥ 15 years ago
  • Pregnant Women
  • Current insulin treatment
  • Treatment with sulfonylureas or glitinides
  • Treatment with a GLP-1 agonist
  • Any other diabetes medication other than an oral agent is exclusionary unless otherwise cleared by medical investigator.
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline and Post-Moderate Hypoxia (14 days)

    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.

Secondary outcomes

  1. Insulin Secretion

    Time frame: Baseline and Post-Moderate Hypoxia (14 days)

    Insulin secretion was determined using an oral glucose tolerance test. Insulin secretion was estimated using the Insulinogenic Index (IGI), an index of first-phase insulin response, and calculated from the ratio of the increments of serum insulin to glucose measured at 30 minutes: IGI (unitless) = (Ins30 - Ins0)/(Glu30 - Glu0), where insulin and glucose from 0 and 30 minutes are used.

  2. Beta-cell Function

    Time frame: Baseline and Post-Moderate Hypoxia (14 days)

    Beta-cell function was determined using an oral glucose tolerance test. Beta-cell function was estimated by the Disposition Index, or the product of insulin sensitivity and insulin secretion: DI (unitless) = Matsuda Index (WBISI) x Insulinogenic Index (IGI).

  3. 2-hour Glucose Area-under-the-curve

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

    2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test.

  4. 2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test

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

    2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: SLEEPDM

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jul 31, 2015
Registry last updated
Oct 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.