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Effect of low-carbohydrate diet in OSA patients treated with long-term CPAP: a multicenter, randomized, open, parallel controlled study

Effect of low-carbohydrate diet in OSA patients treated with long-term CPAP: a multicenter, randomized, open, parallel controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035077
Enrollment
Unknown
Registered
2020-07-30
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea

Interventions

experimental group:low-carbohydrate diet plus CPAP

Sponsors

Guangdong Provincial People's Hospital / Guangdong Academy of Medical Sciences / Guangdong Institute of Geriatrics
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 65 years old, both male and female; 2. Patients with BMI > 25 kg / m2; 3. Patients treated with CPAP for more than one year; 4. Reexamination AHI >= 15 / h without CPAP.

Exclusion criteria

Exclusion criteria: 1. Patients who had standardized weight loss plan 3 months before enrollment, such as weight loss surgery, drug weight loss, etc.; 2. Patients with central sleep apnea accounted for more than 20%; 3. Patients with diabetes mellitus or recurrent gout attacks; 4. Patients with eating disorders or extensive food allergy history; 5. Patients with serious primary heart, liver, kidney and blood system diseases or serious diseases affecting their survival, such as tumor, AIDS, renal dysfunction, cerebral hemorrhage, etc., have a history of surgery in the past year; 6. Subjects with irregular lifestyle in recent three months, such as frequent business trip, social intercourse and night shift, and more than two times a week; 7. Those who are expected to be unable to avoid frequent night shift or business trip in the next three months; 8. Patients with anxiety, depression, mental disorders and other diseases (by case and medication history); 9. Pregnancy, lactation, pregnancy preparation objects; 10. The researcher thinks it is not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Apnea Hyponea Index, AHI;

Secondary

MeasureTime frame
Epworth Sleepiness Scale, ESS;Insomnia Severity Index, ISI;Pittsburgh sleep quality index, PSQI;weight;neck circumference;Waist-hip ratio;body fat rate (%);body fat mass (FM);muscle mas;basal metabolic rate (BMR);visceral fat rating;average oxygen saturation at night;Minimum oxygen saturation at night;sleep efficiency;REM sleep percentage;Oxygen Desaturation Index, ODI;arousal index;APAP treatment pressure;high density lipoprotein (HDL);low density lipoprotein (LDL);Total Cholesterol (TC);glucose;Fasting insulin;liver and kidney function indexes;tumor index;lateral cephalometric radiographs;intestinal flora;oropharyngeal flora;facial images;leptin;Orexin;Dietary structure;energy intake;

Countries

China

Contacts

Public ContactOu Qiong

Guangdong Provincial People's Hospital / Guangdong Academy of Medical Sciences / Guangdong Institute of Geriatrics

ouqiong2776@hotmail.com+86 13609717251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026