Study on the Impact of Fructose Intake on the Circadian Rhythm of Gut Microbiota in Obese Type 2 Diabetes Patients

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400079930

Enrollment

Unknown

Registered

2024-01-16

Start date

2024-01-22

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Type 2 diabetes

Interventions

Treatment group:Oral administration of 75 grams of fructose

Control group:Oral administration of water

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male participants aged between 18 and 65 years old. 2. Healthy subjects: BMI ranging from 18.5 to 24.0 kg/m², in good physical health. 3. Obese Type 2 Diabetes subjects: Meeting the criteria outlined in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2017 Edition)" with a BMI = 28 kg/m² and not currently undergoing antidiabetic medication. 4. Stable weight (weight fluctuations of <5% in the three months preceding enrollment). 5. Willing to sign an informed consent form and adhere to the study protocol.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to or intolerant of fructose. 2. Participants deemed unsuitable or unable to undergo endoscopic colon tube placement, as assessed by a physician. 3. Clinically diagnosed with other endocrine disorders or chronic diseases in other systems, undergoing treatment without adequate control. 4. Use of medications in the past 3 months that may affect weight (such as orlistat, corticosteroids, etc.) or drugs affecting appetite, gastrointestinal motility, antibiotics, PPIs, or other medications influencing gut microbiota. 5. Severe liver dysfunction (ALT = 3 ULN), severe renal insufficiency (eGFR = 60 ml/min/1.73m²), or heart failure (NYHA III-IV). 6. History of weight loss surgery. 7. Weekly alcohol consumption exceeding 140g (for females, >70g) in ethanol equivalent, with a smoking habit. 8. Individuals with mental disorders unable to comply with the trial requirements. 9. History of cancer within the past 5 years.

Design outcomes

Primary

Measure	Time frame
The circadian rhythm of gut microbiota structure and function;	—

Secondary

Measure	Time frame
Fasting blood sugar;Total serum cholesterol;Serum triglyceride;Serum high-density lipoprotein cholesterol;Serum low-density lipoprotein cholesterol;Serum uric acid;	—

Countries

China

Contacts

Public ContactYu Liu

Sir Run Run Hospital, Nanjing Medical University

drliuyu@njmu.edu.cn+86 25 8711 5663

Outcome results

None listed

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