Time Restricted Eating in Sleep Apnea

NCT06047496 | Recruiting Early Phase 1

• 1 other identifier: 807206
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a highly prevalent disorder that is associated with both cardiovascular and metabolic dysfunction, such as hypertension, increased blood glucose levels and diabetes, obesity, and nonalcoholic fatty liver. While continuous positive airway pressure (CPAP), the best available OSA treatment, has been shown to improve blood pressure in OSA, it does not appear to improve metabolic consequences of OSA, and other therapies for OSA-induced dysmetabolism are needed. Animal models of time restricted eating (TRE) demonstrate an improvement in glucose and lipid metabolism, even in the absence of a reduction of caloric intake. Some human studies have shown an improvement in metabolic dysfunction with TRE, though further well-designed studies are needed. The effects of TRE on metabolic dysfunction in patients with OSA, a population with a high predisposition to metabolic disorder, has never been examined. In this study, we will conduct a randomized clinical trial to assess the feasibility and efficacy of 12 weeks of TRE, versus standard eating (SE), to improve glucose regulation and cardiovascular health of participants with OSA.

Conditions

Time Restricted Eating; Obstructive Sleep Apnea

Keywords

hyperglycemia; intermittent fasting; sleep apnea; weight loss; hyperlipidemia; metabolic syndrome

Outcome Measures

Primary Outcomes (4)

• Effect of TRE vs SE on change in mean daily glucose level

  Change in mean daily glucose level over the study duration (measured in mg/dL), derived from continuous glucose monitoring (CGM), is the primary outcome.

  12 weeks

• Effect of TRE vs SE on change in serum LDL cholesterol

  Change in serum LDL (mg/dL), based on fasting blood draws, will be compared between TRE and SE groups.

  12 weeks

• Effect of TRE vs SE on change in OSA severity

  Change in OSA severity (apnea-hypopnea index, number of events per hour) will be compared versus pre-enrollment data.

  12 weeks

• Effect of TRE on quality of life

  Change in quality of life, based on the Short Form (36) Health Survey, will be compared in TRE and SE groups. This survey is a patient-reported scale measuring overall health. It features eight scaled scores, where the scores are the weighted sums in each section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Scores range from 0-100 where lower scores mean more disability, and higher scores mean higher disability.

  12 weeks

Study Arms (2)

Time restricted eating

EXPERIMENTAL

Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period, for 12 weeks.

Behavioral: Time restricted eating

Standard eating

NO INTERVENTION

Normal eating schedule. Participants are expected to maintain their normal eating and dietary habits.

Interventions

Time restricted eating BEHAVIORAL

Caloric intake restricted to a self-defined 8-10 hour window in each 24-hour period.

Time restricted eating

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Be of appropriate age (18-70);
• Own a smartphone (Apple iOS or Android OS);
• Have a baseline eating period ≥12 hours/day and sufficient logging on the myCircadianClock app;
• If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period;
• Have untreated moderate to severe obstructive sleep apnea (OSA, apnea-hypopnea index ≥15 events/hr); and
• Agree to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

You may not qualify if:

• Participants with type 1 or type 2 diabetes mellitus who are taking insulin or sulfonylureas, or any participant with a history of hypoglycemia unawareness
• OSA with evidence of significant sleepiness, as defined by either a) Epworth Sleepiness Score ≥15, or b) motor vehicle accident due to excessive sleepiness within the past year
• BMI \>40 kg/m2
• Uncontrolled hypertension
• Active tobacco or illicit drug use
• Pregnant or breastfeeding women
• Currently enrolled in a weight-loss or weight-management program
• Currently on a special or prescribed diet for other reasons (e.g., Celiac disease)
• Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression
• History of eating disorder(s)
• History of surgical intervention for weight management
• Chronic kidney disease
• Treatment for active inflammatory and/or rheumatologic disease and cancer
• Unrevascularized cardiovascular disease
• Liver cirrhosis and/or significant alterations in liver function

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego (ACTRI)

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting; Sleep Apnea, Obstructive; Hyperglycemia; Sleep Apnea Syndromes; Weight Loss; Hyperlipidemias; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Insulin Resistance; Hyperinsulinism

Study Officials

• Omar Mesarwi, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela DeYoung, RPSGT

CONTACT

(858) 246-2154; pdeyoung@health.ucsd.edu

Omar Mesarwi, MD

CONTACT

(858) 822-1783; omesarwi@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is a parallel study design of TRE vs SE on the outcomes listed. 80 participants will be recruited (40 per group) with an interim analysis performed after 34 participants are recruited (17 per group).

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 21, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)