Intermittent Eating on Glucose Homeostasis in Prediabetes

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jan 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how two different types of intermittent eating—specifically the 5:2 diet and time-restricted eating (TRE)—can affect blood sugar control and overall health in people with prediabetes. Prediabetes means that blood sugar levels are higher than normal but not high enough to be classified as diabetes, and it puts individuals at risk for developing diabetes in the future. The 5:2 diet allows participants to eat normally for five days of the week and restrict their calorie intake on two non-consecutive days. On the other hand, TRE allows participants to eat freely within a specific time frame each day, without limiting the amount they eat. This trial will compare these eating patterns to standard healthcare advice over a period of six months.

To be eligible for this study, participants should be between 18 and 75 years old, have a body mass index (BMI) between 28 and 45, and be diagnosed with prediabetes. Participants will be randomly assigned to one of the eating patterns or to the usual care group, and they can expect to follow the diet for six months while monitoring their health. It's important to note that individuals with certain health conditions, such as diabetes, serious liver or kidney problems, or those who are pregnant, will not be eligible for this trial. This research aims to find out if these new eating patterns can help improve health and prevent diabetes in individuals with prediabetes.

Gender

ALL

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.