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Effect of a diet low in advanced glycation end products on islet function and insulin sensitivity in pre-diabetic individuals: a randomised controlled trial

Effect of a diet low in advanced glycation end products on islet function and insulin sensitivity in pre-diabetic individuals: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089553
Enrollment
Unknown
Registered
2024-09-10
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

pre-diabetic

Interventions

Intervention group:Low advanced glycation end products (AGEs) diet
Control Group:Daily diet (High advanced glycation end products (AGEs) diet

Sponsors

School of Public Health, WuHan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. Males or females aged 19 to 39 years; 2. Prediabetes as defined by the 2023 ADA criteria, meeting any one of the following: i) Impaired fasting glucose: fasting plasma glucose 5.6-6.9 mmol/L; ii) Impaired glucose tolerance: 2-hour plasma glucose value of 7.8-11.0 mmol/L after an oral glucose tolerance test (OGTT); iii) Elevated HbA1c: 5.7-6.4% (39-47 mmol/mol); 3. Body Mass Index (BMI) >=18 kg/m^2; 4. Daily dietary intake of AGEs >=60 mg/day; 5. Willingness to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals diagnosed with diabetes and currently taking antidiabetic medications; 2. Females who are currently pregnant, breastfeeding, or planning to become pregnant within 12 months; 3. Smokers and heavy drinkers (average consumption of more than 5 times per week, with each occasion involving more than 5 bottles of beer or 2 ounces of liquor); 4. Individuals who have undergone weight-loss medication or surgery within the past 3 months; 5. Individuals with acute inflammation (as determined by medical history, physical examination, or laboratory tests); 6. Individuals with cancer, myocardial infarction, or stroke; 7. Individuals with infectious diseases such as tuberculosis or HIV/AIDS; 8. Individuals with severe trauma, recent surgery, or other stressful conditions.

Design outcomes

Primary

MeasureTime frame
blood glucose;insulin;C-peptide;HbA1c;urine advanced glycation end products;fece advanced glycation end products;

Secondary

MeasureTime frame
metabolic indicators;inflammatory indicators;vascular endothelial function;dietary questionnaires;feces;body composition testing;blood advanced glycation end products;

Countries

China

Contacts

Public ContactZhao Lina

School of Public Health, WuHan University

Zhaoln@whu.mail.cn+86 133 2642 2823

Outcome results

None listed

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