Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
NCT Number: NCT04108819
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 respiratory failure, pulmonary hypertension, and death. The cause of OHS is unclear. Since not all obese people develop OHS, it is believed that hormone imbalances can contribute to the breathing problem.
Some diets can change the body's hormones. For example, low-carbohydrate, high fat "ketogenic" diets (KD) may decrease insulin and glucose levels and increase sensitivity to other hormones. The investigators hypothesize that a KD will improve breathing in OHS patients, even in the absence of weight loss.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21224, United States
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 with respiratory failure, pulmonary hypertension, hospital admissions, and death. Unfortunately, there is no treatment for OHS besides massive weight loss which often requires bariatric surgery.
In this study, the investigators are examining whether switching from a regular diet to a ketogenic diet will improve breathing, oxygen, and carbon dioxide levels in OHS patients. After a few days-weeks on KD, hormone changes are known to occur and the investigators are examining whether these hormonal changes could stimulate breathing.
This is a pilot study to examine the effects of a 12 day KD on OHS. The outcomes of the study include blood oxygen, carbon dioxide levels, plasma levels of hormones such as insulin, leptin, sleep studies, body composition a, weight, and metabolic rate.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.
Time frame: Baseline (pre keto diet) and 2 weeks post keto diet
Measured in mmHg.
Time frame: Once per week, over 4 weeks
Measured in moles per liter.
Time frame: Once per week, over 4 weeks
Measured in g/dL.
Time frame: Once per week, over 4 weeks
Measured in mIU/L.
Time frame: Once per week, over 4 weeks
Measured in ng/mL.
Time frame: Once per week, over 4 weeks
Measured in mg/dL.
Time frame: Continuously measured over 4 weeks
Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.
Time frame: Once per week, over 4 weeks
Time frame: Once per week, over 4 weeks
Measured as a percentage.
Time frame: Once per week, over 4 weeks
Measured in mmHg.
Time frame: Once every 2 weeks, over 4 weeks
The investigators will measure percentage body fat using the Bioelectrical impedance analysis (BIA).
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.
Time frame: Once per week, over 4 weeks
Measured in mg/dL.
Time frame: Once per week, over 4 weeks
Measured in mg/dL.
Time frame: Once per week, over 4 weeks
Measured in mg/dL.
Johns Hopkins University
Other
Acronym: KETOHS
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