We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketogenic Diet for Obesity Hypoventilation Syndrome (KETOHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04108819
Recruitment Status : Completed
First Posted : September 30, 2019
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 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.


Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Ketogenic Dieting Hypercapnic Respiratory Failure Dietary Supplement: Ketogenic Diet Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketogenic Diet for Obesity Hypoventilation Syndrome
Actual Study Start Date : October 30, 2019
Actual Primary Completion Date : June 28, 2022
Actual Study Completion Date : June 28, 2022

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Awake venous carbon dioxide (PvCO2) Level [ Time Frame: Baseline (pre keto diet) and 2 weeks post keto diet ]
    Measured in mmHg.


Secondary Outcome Measures :
  1. Change in Venous pH [ Time Frame: Once per week, over 4 weeks ]
    Measured in moles per liter.

  2. Change in Glucose level [ Time Frame: Once per week, over 4 weeks ]
    Measured in g/dL.

  3. Change in Insulin level [ Time Frame: Once per week, over 4 weeks ]
    Measured in mIU/L.

  4. Change in leptin level [ Time Frame: Once per week, over 4 weeks ]
    Measured in ng/mL.

  5. Change in beta-Hydroxybutyrate level [ Time Frame: Once per week, over 4 weeks ]
    Measured in mg/dL.

  6. Glucose profile [ Time Frame: Continuously measured over 4 weeks ]
    Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.

  7. Change in Body weight (kg) [ Time Frame: Once per week, over 4 weeks ]
  8. Change in Oxygen saturation [ Time Frame: Once per week, over 4 weeks ]
    Measured as a percentage.

  9. Change in Blood Pressure [ Time Frame: Once per week, over 4 weeks ]
    Measured in mmHg.

  10. 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).

  11. 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.

  12. Change in LDL Cholesterol [ Time Frame: Once per week, over 4 weeks ]
    Measured in mg/dL.

  13. Change in HDL Cholesterol [ Time Frame: Once per week, over 4 weeks ]
    Measured in mg/dL.

  14. Change in Triglyceride level [ Time Frame: Once per week, over 4 weeks ]
    Measured in mg/dL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Jun, MD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04108819    
Other Study ID Numbers: IRB00212924
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases