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Ketogenic Diet for Obesity Hypoventilation Syndrome (KETOHS)

Primary Purpose

Obesity Hypoventilation Syndrome, Ketogenic Dieting, Hypercapnic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic Diet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity Hypoventilation Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketogenic Diet

Arm Description

Participants will receive the ketogenic diet.

Outcomes

Primary Outcome Measures

Change in Awake venous carbon dioxide (PvCO2) Level
Measured in mmHg.

Secondary Outcome Measures

Change in Venous pH
Measured in moles per liter.
Change in Glucose level
Measured in g/dL.
Change in Insulin level
Measured in mIU/L.
Change in leptin level
Measured in ng/mL.
Change in beta-Hydroxybutyrate level
Measured in mg/dL.
Glucose profile
Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.
Change in Body weight (kg)
Change in Oxygen saturation
Measured as a percentage.
Change in Blood Pressure
Measured in mmHg.
Change in percentage of body fat
The investigators will measure percentage body fat using the Bioelectrical impedance analysis (BIA).
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.
Change in LDL Cholesterol
Measured in mg/dL.
Change in HDL Cholesterol
Measured in mg/dL.
Change in Triglyceride level
Measured in mg/dL.

Full Information

First Posted
September 26, 2019
Last Updated
June 28, 2022
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04108819
Brief Title
Ketogenic Diet for Obesity Hypoventilation Syndrome
Acronym
KETOHS
Official Title
Ketogenic Diet for Obesity Hypoventilation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome, Ketogenic Dieting, Hypercapnic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic Diet
Arm Type
Experimental
Arm Description
Participants will receive the ketogenic diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic Diet
Intervention Description
Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.
Primary Outcome Measure Information:
Title
Change in Awake venous carbon dioxide (PvCO2) Level
Description
Measured in mmHg.
Time Frame
Baseline (pre keto diet) and 2 weeks post keto diet
Secondary Outcome Measure Information:
Title
Change in Venous pH
Description
Measured in moles per liter.
Time Frame
Once per week, over 4 weeks
Title
Change in Glucose level
Description
Measured in g/dL.
Time Frame
Once per week, over 4 weeks
Title
Change in Insulin level
Description
Measured in mIU/L.
Time Frame
Once per week, over 4 weeks
Title
Change in leptin level
Description
Measured in ng/mL.
Time Frame
Once per week, over 4 weeks
Title
Change in beta-Hydroxybutyrate level
Description
Measured in mg/dL.
Time Frame
Once per week, over 4 weeks
Title
Glucose profile
Description
Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.
Time Frame
Continuously measured over 4 weeks
Title
Change in Body weight (kg)
Time Frame
Once per week, over 4 weeks
Title
Change in Oxygen saturation
Description
Measured as a percentage.
Time Frame
Once per week, over 4 weeks
Title
Change in Blood Pressure
Description
Measured in mmHg.
Time Frame
Once per week, over 4 weeks
Title
Change in percentage of body fat
Description
The investigators will measure percentage body fat using the Bioelectrical impedance analysis (BIA).
Time Frame
Once every 2 weeks, over 4 weeks
Title
Change in Apnea Hypopnea Index
Description
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 every 2 weeks, over 4 weeks
Title
Change in LDL Cholesterol
Description
Measured in mg/dL.
Time Frame
Once per week, over 4 weeks
Title
Change in HDL Cholesterol
Description
Measured in mg/dL.
Time Frame
Once per week, over 4 weeks
Title
Change in Triglyceride level
Description
Measured in mg/dL.
Time Frame
Once per week, over 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Jun, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ketogenic Diet for Obesity Hypoventilation Syndrome

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