Effect of Hypoglycemia on Sleep

Completed · Not applicable

Conditions studied: Hypoglycemia

In brief

Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported, and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic hypoglycemia is a limitation of current intensive insulin therapies. Although severe hypoglycemia is associated with adverse events such as seizures and death, less severe nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response, leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle. The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.

Key facts

Study ID

NCT02687893

Run by

Oregon Health and Science University

People needed

10

Starts

2016-02-01

Expected to finish

2018-07-18

Last updated by the study team

2019-04-10

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female subjects 21 to 45 years of age.
• Physically active on a regular basis, i.e. at least 3 days of physical activity per week.
• Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
• Current use of an insulin pump.
• Willingness to follow all study procedures, including attending all clinic visits.
• Willingness to sign informed consent and HIPAA documents.

You may not qualify if…

• Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
• Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
• Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
• Hematocrit of less than or equal to 34%.
• History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
• Adrenal insufficiency.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use).
• Seizure disorder.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Major surgical operation within 30 days prior to screening.
• Use of an investigational drug within 30 days prior to screening.
• Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
• Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
• Insulin resistance requiring more than 200 units per day.
• Need for uninterrupted treatment with acetaminophen.
• Current administration of oral or parenteral corticosteroids.
• Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
• C peptide level of ≥0.5 ng/ml
• Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
• Beta blockers or non-dihydropyridine calcium channel blockers.
• A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
• Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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