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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet | Experimental | Participants will receive the ketogenic diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Dietary Supplement | Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Awake venous carbon dioxide (PvCO2) Level | Measured in mmHg. | Baseline (pre keto diet) and 2 weeks post keto diet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Venous pH | Measured in moles per liter. | Once per week, over 4 weeks |
| Change in Glucose level | Measured in g/dL. | Once per week, over 4 weeks |
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Exclusion Criteria:
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https://mrprcbcw.hosts.jhmi.edu/redcap/surveys/?s=RYX7DELK9Y
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Jun, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D010845 | Obesity Hypoventilation Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Change in Insulin level | Measured in mIU/L. | Once per week, over 4 weeks |
| Change in leptin level | Measured in ng/mL. | Once per week, over 4 weeks |
| Change in beta-Hydroxybutyrate level | Measured in mg/dL. | Once per week, over 4 weeks |
| Glucose profile | Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home. | Continuously measured over 4 weeks |
| Change in Body weight (kg) | Once per week, over 4 weeks |
| Change in Oxygen saturation | Measured as a percentage. | Once per week, over 4 weeks |
| Change in Blood Pressure | Measured in mmHg. | Once per week, over 4 weeks |
| Change in percentage of body fat | The investigators will measure percentage body fat using the Bioelectrical impedance analysis (BIA). | Once every 2 weeks, over 4 weeks |
| Change in Apnea Hypopnea Index | 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. | Once every 2 weeks, over 4 weeks |
| Change in LDL Cholesterol | Measured in mg/dL. | Once per week, over 4 weeks |
| Change in HDL Cholesterol | Measured in mg/dL. | Once per week, over 4 weeks |
| Change in Triglyceride level | Measured in mg/dL. | Once per week, over 4 weeks |
| D012140 |
| Respiratory Tract Diseases |
| D007040 | Hypoventilation |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |