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Novel Inhibitors of Lipolysis in the Treatment of Lipid a Glucose Metabolism in Obstructive Sleep Apnea Syndrome

NCT05245240 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-17

No results posted yet for this study

Summary

Obstructive sleep apnea syndrome (OSA) represents highly prevalent (typically overlooked, undiagnosed and untreated) disorder significantly increasing cardiovascular, cancer and overall mortality as well as increasing the risk of Type 2 diabetes and liver steatohepatitis. Unfortunately, adherence to state-of-the-art therapy with continuous positive airway pressure devices (CPAP) is poorly tolerated by patients, rendering a significant proportion (\~60-70 %) of them at undiminished cardiovascular and metabolic risk warranting development of innovative, pharmacological, treatment options.

The overarching theme of this project is that metabolic impairments associated with OSA (e.g. Type 2 diabetes mellitus and non-alcoholic steatohepatitis) are causally mediated by elevated levels of circulating free fatty acids (FFA) originating from hypoxia-induced adipose tissue lipolysis. Increased plasma FFA subsequently induce insulin resistance, β-cell dysfunction, increase hepatic glucose output and stimulate lipid storage in liver. The investigators recently proved that hypoxia represents a powerful stimulus for adipocyte lipolysis and that experimental pharmacological inhibition of lipolysis prevented development of Type 2 diabetes in a mouse model of OSA. The goal of the project is to understand adipose tissue lipolysis derangements in OSA subjects and to evaluate the feasibility of lifestyle intervention as a mean to reduce spontaneous lipolysis.

Conditions

Interventions

PROCEDURE

Dietary and physical intervention

Low-caloric diet (energy deficit 600 kcal/day based on indirect calorimetry measurements), individually tailored by a nutritional specialist according to patients' individual food preferences. Mild to moderate intensity exercise of aerobic/endurance type, performed 3 times a week for 30-90 minutes.

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    lead OTHER_GOV

Principal Investigators

  • Jan Polak, MD, PhD · Vascular surgery, University hospital Královské Vinohrady, Prague

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245240 on ClinicalTrials.gov