Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism

NCT01503164 | Completed Results DMC

• 2 other identifiers: NA_000366722R01HL075078
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea affects approximately 2-4% of middle-aged adults in the general population and is associated with several medical conditions including hypertension and coronary artery. Research over the last decade has shown that obstructive sleep apnea may also increase the propensity for insulin resistance, glucose intolerance, and type 2 diabetes mellitus. Positive airway pressure (PAP) is the first line therapy for the treatment of obstructive sleep apnea. While PAP therapy has several favorable effects such as improvements in daytime sleepiness and quality of life, it is not clear whether using PAP therapy can alter metabolic risk. The overall objective of this study is to examine whether treatment of obstructive sleep apnea with positive airway pressure therapy improves glucose tolerance and insulin sensitivity. The primary hypothesis of this study is that PAP therapy of obstructive sleep apnea will improve in insulin sensitivity and glucose metabolism.

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Sleep-disordered Breathing

Keywords

Obstructive sleep apnea; Sleep Apnea; Sleep-disordered breathing; Insulin sensitivity; Glucose tolerance; Type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Insulin Sensitivity (SI)

  Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time "zero". After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the "minimal model" (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.

  Baseline

• Insulin Sensitivity (SI)

  Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time "zero". After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the "minimal model" (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.

  2 months after intervention

Secondary Outcomes (10)

• Glucose Effectiveness (SG)

  Baseline

• Glucose Effectiveness (SG)

  2 months after intervention

• Disposition Index (DI)

  Baseline

• Disposition Index (DI)

  2 months after intervention

• Acute Insulin Response to Glucose (AIRG)

  Baseline

Study Arms (2)

Positive pressure therapy (PAP)

ACTIVE COMPARATOR

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Device: Positive Pressure Therapy (PAP)

Lifestyle counseling

SHAM COMPARATOR

Behavioral: LifeStyle Counseling

Interventions

Positive Pressure Therapy (PAP) DEVICE

Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Also known as: CPAP

Positive pressure therapy (PAP)

LifeStyle Counseling BEHAVIORAL

Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Also known as: Dietary and Lifestyle Counseling

Lifestyle counseling

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent
• Obstructive sleep apnea (untreated)
• Ability to comply with study-related assessments

You may not qualify if:

• Inability to consent or commit to the required visits
• Diabetes mellitus (fasting glucose \> 126 mg/dl)
• Use of insulin or oral hypoglycemic agent
• Weight change of 10% in last six months
• Use of oral steroids in the last six months
• Severe pulmonary disease (i.e., COPD)
• Renal or hepatic insufficiency
• Recent Myocardial Infarction (MI) or stroke (\< 3 months)
• Occupation as a commercial driver
• Active substance use
• Untreated thyroid disease
• Pregnancy
• Anemia (Hematocrit \< 30%)
• Any history of seizures or other neurologic disease
• Poor sleep hygiene or sleep disorder other than sleep apnea

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

• Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.

  PMID: 11991871 BACKGROUND

• Punjabi NM, Ahmed MM, Polotsky VY, Beamer BA, O'Donnell CP. Sleep-disordered breathing, glucose intolerance, and insulin resistance. Respir Physiol Neurobiol. 2003 Jul 16;136(2-3):167-78. doi: 10.1016/s1569-9048(03)00079-x.

  PMID: 12853008 BACKGROUND

• Tasali E, Mokhlesi B, Van Cauter E. Obstructive sleep apnea and type 2 diabetes: interacting epidemics. Chest. 2008 Feb;133(2):496-506. doi: 10.1378/chest.07-0828.

  PMID: 18252916 BACKGROUND

• Punjabi NM; Workshop Participants. Do sleep disorders and associated treatments impact glucose metabolism? Drugs. 2009;69 Suppl 2:13-27. doi: 10.2165/11531150-000000000-00000.

  PMID: 20047348 BACKGROUND

• Aurora RN, Swartz R, Punjabi NM. Misclassification of OSA severity with automated scoring of home sleep recordings. Chest. 2015 Mar;147(3):719-727. doi: 10.1378/chest.14-0929.

  PMID: 25411804 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Naresh Punjabi
• Organization: Johns Hopkins University

npunjabi@jhmi.edu

410-550-6384

Study Officials

• Naresh M Punjabi, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 2, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 19, 2017
• Results First Posted: October 19, 2017

Record last verified: 2017-10

Locations

US (1)