Obesity Hypoventilation SyndromeKETOHSNCT04108819
Ketogenic Diet for Obesity Hypoventilation Syndrome
A study testing Ketogenic Diet in people with Obesity Hypoventilation Syndrome and Ketogenic Dieting, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Hypoventilation Syndrome, Ketogenic Dieting, Hypercapnic Respiratory Failure
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read the 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.
- Being tested
- Ketogenic Diet
- Medical subject headings
- Obesity Hypoventilation Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietDietary supplement
Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | Participants will receive the ketogenic diet. Receives: Dietary Supplement: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Awake venous carbon dioxide (PvCO2) Level
Measured in mmHg.
Measured: Baseline (pre keto diet) and 2 weeks post keto diet
Secondary outcomes (14)
Change in Venous pH
Measured in moles per liter.
Measured: Once per week, over 4 weeks
Change in Glucose level
Measured in g/dL.
Measured: Once per week, over 4 weeks
Change in Insulin level
Measured in mIU/L.
Measured: Once per week, over 4 weeks
Change in leptin level
Measured in ng/mL.
Measured: Once per week, over 4 weeks
Change in beta-Hydroxybutyrate level
Measured in mg/dL.
Measured: Once per week, over 4 weeks
Glucose profile
Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.
Measured: Continuously measured over 4 weeks
Change in Body weight (kg)
Measured: Once per week, over 4 weeks
Change in Oxygen saturation
Measured as a percentage.
Measured: Once per week, over 4 weeks
Change in Blood Pressure
Measured in mmHg.
Measured: 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).
Measured: 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.
Measured: Once every 2 weeks, over 4 weeks
Change in LDL Cholesterol
Measured in mg/dL.
Measured: Once per week, over 4 weeks
Change in HDL Cholesterol
Measured in mg/dL.
Measured: Once per week, over 4 weeks
Change in Triglyceride level
Measured in mg/dL.
Measured: Once per week, over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start30 Oct 2019
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Jun, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108819
- Sponsor's protocol ID
- IRB00212924
- Acronym
- KETOHS
- Status last verified
- Jun 2022
- First submitted
- 26 Sep 2019
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet for Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT04108819
- Acronym / sponsor ID
- KETOHS / IRB00212924
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Dietary Supplement: Ketogenic DietParticipants will receive the ketogenic diet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic DietSubjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period. | Dietary supplement | Ketogenic Diet |
Primary outcome
Change in Awake venous carbon dioxide (PvCO2) Level
Time frame: Baseline (pre keto diet) and 2 weeks post keto diet
Measured in mmHg.
14 secondary outcomes
Change in Venous pH
Time frame: Once per week, over 4 weeks
Change in Glucose level
Time frame: Once per week, over 4 weeks
Change in Insulin level
Time frame: Once per week, over 4 weeks
Change in leptin level
Time frame: Once per week, over 4 weeks
Change in beta-Hydroxybutyrate level
Time frame: Once per week, over 4 weeks
Glucose profile
Time frame: Continuously measured over 4 weeks
Change in Body weight (kg)
Time frame: Once per week, over 4 weeks
Change in Oxygen saturation
Time frame: Once per week, over 4 weeks
Change in Blood Pressure
Time frame: Once per week, over 4 weeks
Change in percentage of body fat
Time frame: Once every 2 weeks, over 4 weeks
Change in Apnea Hypopnea Index
Time frame: Once every 2 weeks, over 4 weeks
Change in LDL Cholesterol
Time frame: Once per week, over 4 weeks
Change in HDL Cholesterol
Time frame: Once per week, over 4 weeks
Change in Triglyceride level
Time frame: Once per week, over 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Jun, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Obesity Hypoventilation Syndrome and Ketogenic Dieting, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Awake venous carbon dioxide (PvCO2) Level (time frame: Baseline (pre keto diet) and 2 weeks post keto diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.