CLINICAL TRIAL

Ketogenic Diet for Obesity Hypoventilation Syndrome

Recruiting · 18+ · All Sexes · Baltimore, MD

Ketogenic Diet for Obesity Hypoventilation Syndrome

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About the trial for Obesity Hypoventilation Syndrome

Eligible Conditions
Respiratory Insufficiency · Ketogenic Dieting · Obesity · Hypercapnic Respiratory Failure · Hypoventilation · Obesity Hypoventilation Syndrome · Syndrome

Treatment Groups

This trial involves 2 different treatments. Ketogenic Diet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ketogenic Diet
DIETARYSUPPLEMENT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketogenic Diet
2016
N/A
~370

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Once every 2 weeks, over 4 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: Once every 2 weeks, over 4 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Once every 2 weeks, over 4 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ketogenic Diet will improve 1 primary outcome and 14 secondary outcomes in patients with Obesity Hypoventilation Syndrome. Measurement will happen over the course of Baseline (pre keto diet) and 2 weeks post keto diet.

Change in Awake venous carbon dioxide (PaCO2) Level
BASELINE (PRE KETO DIET) AND 2 WEEKS POST KETO DIET
Measured in mmHg.
BASELINE (PRE KETO DIET) AND 2 WEEKS POST KETO DIET
Glucose profile
CONTINUOUSLY MEASURED OVER 4 WEEKS
Using continuous glucose monitoring (CGM), to measured glucose level (g/dL) each day at home.
CONTINUOUSLY MEASURED OVER 4 WEEKS
Change in beta-Hydroxybutyrate level
ONCE PER WEEK, OVER 4 WEEKS
Measured in mg/dL.
ONCE PER WEEK, OVER 4 WEEKS
Change in leptin level
ONCE PER WEEK, OVER 4 WEEKS
Measured in ng/mL.
ONCE PER WEEK, OVER 4 WEEKS
Change in Glucose level
ONCE PER WEEK, OVER 4 WEEKS
Measured in g/dL.
ONCE PER WEEK, OVER 4 WEEKS
Change in Blood Pressure
ONCE PER WEEK, OVER 4 WEEKS
Measured in mmHg.
ONCE PER WEEK, OVER 4 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can obesity hypoventilation syndrome be cured?

In our series, only five patients achieved resolution of OHS symptoms. On a group level, overweight patients with OHS benefited less from CPAP therapy. Therefore, CPAP should be prescribed to only lean patients.

Anonymous Patient Answer

What are common treatments for obesity hypoventilation syndrome?

Most patients with obstructive sleep apnea show symptomatic improvement with CPAP. The addition of weight loss may improve exercise habits and reduce nocturnal hypoxia, which is an independent risk factor for apnea.

Anonymous Patient Answer

What is obesity hypoventilation syndrome?

Obesity hypoventilation syndrome has been termed by many different names, and is likely a complex syndrome defined by a collection of features and associated conditions. The medical treatment depends on the specific problem, including whether this is an issue in the primary prevention setting.

Anonymous Patient Answer

What are the signs of obesity hypoventilation syndrome?

Obese patients can have a variety of respiratory complaints including increased work of breathing, rapid shallow breathing pattern, and/or increased dyspnea. Many patients do not have OHS and are not diagnosed with respiratory problems and will be left untreated.

Anonymous Patient Answer

What causes obesity hypoventilation syndrome?

Obesity hypoventilation syndrome (OHS) is characterized by increased alveolar ventilation in the presence of normal lung volumes which is not seen with obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) (OSA). The central circadian drive that generates arousal from sleep in OSA is not present in OHS. The primary cause of OHS remains unknown. The clinical presentation of OHS may reflect increased sympathetic nervous system activity and increased plasma cortisol levels.

Anonymous Patient Answer

How many people get obesity hypoventilation syndrome a year in the United States?

Obesity hypoventilation syndrome is diagnosed in a substantial number of people annually. It is associated with significant morbidity and mortality. This article includes a videotape of an educational session given at the National Obesity Association Convention and Exhibition.

Anonymous Patient Answer

What are the latest developments in ketogenic diet for therapeutic use?

More recent findings show that the ketogenic diet was better than the standard, high-carbohydrate diet in treatment of the adults with the intractable neurodegenerative diseases. Furthermore, the ketogenic diet is well suited to treatment of the conditions caused by congenital diseases, such as epilepsy and muscular dystrophy. It is of major importance to the public, that it is still unclear when will be the ketogenic diet be commercially available. The ketogenic diet is most effective against epileptic seizures which is important to all patients with uncontrolled or intractable epilepsy, for the treatment of children or adults.

Anonymous Patient Answer

Is ketogenic diet typically used in combination with any other treatments?

Although there were no significant differences between the BD-only group and the BD-co-morbid group based on the mean of the number and the magnitude of the side effects, it seems that a combination of other treatments may be useful to improve the treatment efficacy to treat and prevent the hypoxic episodes in patients with refractory epilepsy.

Anonymous Patient Answer

What is the average age someone gets obesity hypoventilation syndrome?

Obesity hypoventilation syndrome appears in all age groups, more often in men older than 50 years, and less often in African American obese infants or toddlers, and in obese male adolescents.

Anonymous Patient Answer

What does ketogenic diet usually treat?

The data suggest the need to re-evaluate current treatments for OHS, and there is a need for greater research into the role of dietary fat in OHS, including an increase in animal-based research.

Anonymous Patient Answer

Does obesity hypoventilation syndrome run in families?

This retrospective study supports the notion that a significant number of patients with obesity hypoventilation syndrome may have familial disease. Results from a recent paper underscore the need for intensified prospective screening of members of this syndrome for both obesity and hypoventilation.

Anonymous Patient Answer

What are the common side effects of ketogenic diet?

The ketogenic diet is not completely free from side effects. The most frequent are gastrointestinal complaints, which may be partially caused by the low insulin levels. To minimize the risk of adverse effects of the diet, it is recommended to have regular blood sugar testing to detect any hypoglycaemic symptoms and to check the levels of insulin, ketones, ketones, and fat in the blood daily. Although the majority of adults who go on the diet do feel some hunger, the short duration of a calorie-restricted diet reduces this to acceptable levels. Some subjects feel some hunger in the early phase of the diet, but they get over it quickly. Patients should use the information as a guide to help them choose the right diet for them.

Anonymous Patient Answer
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