Effects of Intermittent Eating on Blood Sugar Levels in Prediabetes

Effects of Intermittent Eating on Glucose Homeostasis in Prediabetes: A Randomized Clinical Trial

This study is testing whether two types of intermittent fasting can help people with prediabetes improve their blood sugar levels and overall health compared to regular eating habits.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05717387 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of two types of intermittent fasting—time-restricted eating (TRE) and the 5:2 diet—on glucose homeostasis and cardiometabolic risk factors in individuals with prediabetes. Participants will undergo an 8-week run-in phase on a low-calorie diet before being randomly assigned to one of three groups: TRE, the 5:2 diet, or a control group. The TRE group will eat within an 8-hour window daily, while the 5:2 diet group will consume a significantly reduced calorie intake on two designated fasting days each week. The study aims to evaluate these dietary interventions over a 6-month period compared to usual health care practices.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with a body mass index (BMI) between 28.0 and 45.0 kg/m2 who have been diagnosed with prediabetes.

Not a fit: Patients with a history of diabetes, serious cardiovascular diseases, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective dietary strategies for improving blood sugar control and reducing the risk of diabetes in prediabetic patients.

How similar studies have performed: Preliminary evidence suggests that similar dietary interventions have shown beneficial effects on glucose control in type 2 diabetes, indicating potential success for this approach in prediabetes.

Eligibility criteria

Inclusion Criteria:

1. Men or women aged 18-75 years;
2. Prediabetes;
3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;

Exclusion Criteria:

1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
2. Diagnosis of type 1 and type 2 diabetes;
3. History of malignant tumors;
4. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
8. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
9. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
10. Currently participating in weight loss programs;
11. Women who are pregnant or plan to become pregnant;
12. Patients who cannot be followed for 24 months (due to a health situation or migration);
13. Patients who are unwilling or unable to give informed consent.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Huijie Zhang, MD.PhD — Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
• Study coordinator: Huijie Zhang, MD.PhD

Conditions PreDiabetes; Obesity; TRE; The 5:2 diet; Glucose Homeostasis; prediabetes; obesity