Ketogenic Diet for Obesity Hypoventilation Syndrome

NCT04108819 | Completed

• 1 other identifier: IRB00212924
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Hypoventilation Syndrome; Ketogenic Dieting; Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Change in Awake venous carbon dioxide (PvCO2) Level

  Measured in mmHg.

  Baseline (pre keto diet) and 2 weeks post keto diet

Secondary Outcomes (14)

• Change in Venous pH

  Once per week, over 4 weeks

• Change in Glucose level

  Once per week, over 4 weeks

• Change in Insulin level

  Once per week, over 4 weeks

• Change in leptin level

  Once per week, over 4 weeks

• Change in beta-Hydroxybutyrate level

  Once per week, over 4 weeks

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

Participants will receive the ketogenic diet.

Dietary Supplement: Ketogenic Diet

Interventions

Ketogenic Diet DIETARY_SUPPLEMENT

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

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Respiratory Insufficiency

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jonathan Jun, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: October 30, 2019
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

US (1)