Ketogenic Diet for Obesity Hypoventilation Syndrome (KETOHS)
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|ClinicalTrials.gov Identifier: NCT04108819|
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Obesity hypoventilation syndrome (OHS) causes hypercapnia (PaCO2>45) in subjects with obesity in the absence of lung disease, and is associated with respiratory failure, pulmonary hypertension, ICU admission, and death. Obesity is necessary, but not sufficient to cause OHS. Neuro-hormonal dysfunction is believed to impair respiratory CO2 sensitivity. In particular, leptin may play a role in OHS pathogenesis. In OHS, leptin levels are greatly elevated and correlate positively with PaCO2 independent of obesity or fat mass which suggests a linkage between defective central satiety and respiratory signaling.
Leptin resistance may be induced by carbohydrate-rich diets while very low carbohydrate "ketogenic" diets (KD) may enhance leptin sensitivity. The investigators hypothesize that a KD will correct hypoventilation in OHS patients, even in the absence of weight loss.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hypoventilation Syndrome Ketogenic Dieting Hypercapnic Respiratory Failure||Dietary Supplement: Ketogenic Diet||Not Applicable|
Prolonged starvation ketosis increased ventilatory responses to inhaled CO2 in obese, mild OHS patients. The investigators anticipate that this phenomenon can be induced by high-fat, low carbohydrate KD instead of an extreme and protracted fast; correct hypoventilation rapidly, since "ketosis" and leptin responses occur within 1 week of a KD; and be feasibly administered to patients with severe OHS, normalizing patients' gas exchange during wakefulness and while asleep.
This is a pilot study to test these hypotheses in patients with OHS. The investigators will enroll patients with OHS, to examine the subacute effects of KD (12 days) on OHS respiratory and neuro-endocrine physiology.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ketogenic Diet for Obesity Hypoventilation Syndrome|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Ketogenic Diet
Participants will receive the ketogenic diet.
Dietary Supplement: Ketogenic Diet
Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.
- Change in Awake venous carbon dioxide (PaCO2) Level [ Time Frame: Baseline (pre keto diet) and 2 weeks post keto diet ]Measured in mmHg.
- Change in Venous pH [ Time Frame: Once per week, over 4 weeks ]Measured in moles per liter.
- Change in Glucose level [ Time Frame: Once per week, over 4 weeks ]Measured in g/dL.
- Change in Insulin level [ Time Frame: Once per week, over 4 weeks ]Measured in mIU/L.
- Change in leptin level [ Time Frame: Once per week, over 4 weeks ]Measured in ng/mL.
- Change in beta-Hydroxybutyrate level [ Time Frame: Once per week, over 4 weeks ]Measured in mg/dL.
- Glucose profile [ Time Frame: Continuously measured over 4 weeks ]Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.
- Change in Body weight (kg) [ Time Frame: Once per week, over 4 weeks ]
- Change in Oxygen saturation [ Time Frame: Once per week, over 4 weeks ]Measured as a percentage.
- Change in Blood Pressure [ Time Frame: Once per week, over 4 weeks ]Measured in mmHg.
- Change in percentage of body fat [ Time Frame: Once every 2 weeks, over 4 weeks ]The investigators will measure percentage body fat using the Bioelectrical impedance analysis (BIA).
- Change in Apnea Hypopnea Index [ Time Frame: Once every 2 weeks, over 4 weeks ]The apnea hypopnea index (AHI) is derived from combined information from EEG signals, flow sensors, respiratory belts, and carbon dioxide censors and is a measure of severity of sleep apnea. AHI < 5 is considered normal. AHI 5-15 is considered mild sleep apnea. AHI 15-30 is considered moderate sleep apnea. AHI >30 is considered severe sleep apnea.
- Change in LDL Cholesterol [ Time Frame: Once per week, over 4 weeks ]Measured in mg/dL.
- Change in HDL Cholesterol [ Time Frame: Once per week, over 4 weeks ]Measured in mg/dL.
- Change in Triglyceride level [ Time Frame: Once per week, over 4 weeks ]Measured in mg/dL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108819
|Contact: David Kim, MDemail@example.com|
|Contact: Jonathan Jun, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Jonathan Jun, MD||Johns Hopkins University|