Ketogenic Diet for Obesity Hypoventilation Syndrome

Hypercapnic Respiratory Failure Clinical Trial

— KETOHS  

Official title:

Ketogenic Diet for Obesity Hypoventilation Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108819
• Other study ID #: IRB00212924
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: June 28, 2022

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Hypercapnic Respiratory Failure
• Hypoventilation
• Ketogenic Dieting
• Obesity
• Obesity Hypoventilation Syndrome
• Respiratory Insufficiency
• Syndrome

Intervention

Dietary Supplement:
• Ketogenic Diet
Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Awake venous carbon dioxide (PvCO2) Level	Measured in mmHg.	Baseline (pre keto diet) and 2 weeks post keto diet
Secondary	Change in Venous pH	Measured in moles per liter.	Once per week, over 4 weeks
Secondary	Change in Glucose level	Measured in g/dL.	Once per week, over 4 weeks
Secondary	Change in Insulin level	Measured in mIU/L.	Once per week, over 4 weeks
Secondary	Change in leptin level	Measured in ng/mL.	Once per week, over 4 weeks
Secondary	Change in beta-Hydroxybutyrate level	Measured in mg/dL.	Once per week, over 4 weeks
Secondary	Glucose profile	Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.	Continuously measured over 4 weeks
Secondary	Change in Body weight (kg)		Once per week, over 4 weeks
Secondary	Change in Oxygen saturation	Measured as a percentage.	Once per week, over 4 weeks
Secondary	Change in Blood Pressure	Measured in mmHg.	Once per week, over 4 weeks
Secondary	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
Secondary	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
Secondary	Change in LDL Cholesterol	Measured in mg/dL.	Once per week, over 4 weeks
Secondary	Change in HDL Cholesterol	Measured in mg/dL.	Once per week, over 4 weeks
Secondary	Change in Triglyceride level	Measured in mg/dL.	Once per week, over 4 weeks