Status:
COMPLETED
Ketogenic Diet for Obesity Hypoventilation Syndrome
Lead Sponsor:
Johns Hopkins University
Conditions:
Obesity Hypoventilation Syndrome
Ketogenic Dieting
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Obesity hypoventilation syndrome (OHS) is a condition that occurs in small percentage of obese people that causes high carbon dioxide and low oxygen levels in the blood. OHS is associated with respira...
Detailed Description
Obesity hypoventilation syndrome (OHS) is a condition that occurs in small percentage of obese people, that leads to high carbon dioxide levels and low oxygen levels in the blood. OHS is associated wi...
Eligibility Criteria
Inclusion
- Obesity (BMI≥30 kg/m2)
- Hypercapnia (PaCO2\>45 or PvCO2\>50) on blood gas, OR a sleep study with end-tidal/transcutaneous CO2 monitoring showing an awake CO2 level \>50
- Participants without blood gas data may also have suspected OHS on the basis of serum bicarbonate \>=28 mEq/L
- Lack of an alternative pulmonary diagnosis that adequately explains hypercapnia. Note that a documented pulmonary diagnosis (e.g. chronic obstructive pulmonary disease (COPD) or asthma) per se will not necessarily exclude subjects, since OHS is often misdiagnosed as obstructive lung disease. Functional or radiographic data must corroborate the presence of the alternate diagnosis.
- Subjects must have had a sleep study and clinical evaluation for sleep apnea. Most subjects with OHS are expected to have concomitant obstructive sleep apnea (OSA). This information is necessary to determine whether continuous positive airway pressure (CPAP)/noninvasive ventilation (NIV) will be used on the research sleep studies.
Exclusion
- Concomitant participation in another weight loss or diet program
- Patients with diabetes taking Sodium-glucose Cotransporter-2 (SGLT2) inhibitors (due to risk of diabetic ketoacidosis)
- Patients with type 1 diabetes
- Any patients with a history of diabetic ketoacidosis
- Patients with incomplete sleep apnea diagnosis or management (i.e. those still acclimating to CPAP, or pending therapeutic decisions about OSA management)
- Known or suspected abuse of narcotics or alcohol
- Liver cirrhosis
- Uncontrolled gout
- History of chronic renal insufficiency requiring dialysis
- Females who are pregnant, breast-feeding, or intending to become pregnant
- Food allergies or diet restrictions that research nutritionists cannot accommodate
- FOLLOW THIS LINK TO SEE IF YOU QUALIFY:
- https://mrprcbcw.hosts.jhmi.edu/redcap/surveys/?s=RYX7DELK9Y
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04108819
Start Date
October 30 2019
End Date
June 28 2022
Last Update
July 1 2022
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224