Clinical trial NCT05717387: Intermittent Eating on Glucose Homeostasis in Prediabetes
Official title: Effects of Intermittent Eating on Glucose Homeostasis in Prediabetes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Obesity
Keywords: TRE
The 5:2 diet
Glucose Homeostasis
prediabetes
obesity
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.

Detailed description: Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on glucose control in type 2 diabetes. No much is known about the effects and molecular mechanisms by TRE or the 5:2 diet improves glucose homeostasis in prediabetes. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care. All eligible participants will participate in an 8-week run-in phase in which they are fed the low-calorie-diet. Participants who pass the run-in phase will be randomly assigned 1:1:1 to one of the three study groups (TRE, the 5:2 diet and control groups). Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.

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.

Primary outcomes:
measure: Change in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.
timeFrame: Baseline to months 6
Secondary outcomes:
measure: Change in mean glucose levels
timeFrame: Baseline and months 6
measure: Change in glycemic variability
timeFrame: Baseline and months 6
measure: Change in percent of time below range
timeFrame: Baseline and months 6
measure: Change in percent of time above range
timeFrame: Baseline and months 6
measure: Change in resting metabolic rate
timeFrame: Baseline and months 6
measure: Change in gut microbiome composition
timeFrame: Baseline and months 6
measure: Change in bile acid level
timeFrame: Baseline and months 6
measure: Change in body weight
timeFrame: Baseline and months 6
measure: Change in body composition
timeFrame: Baseline and months 6
measure: Change in waist circumference
timeFrame: Baseline and months 6
measure: Change in body mass index
timeFrame: Baseline and months 6
measure: Change in liver fat
timeFrame: Baseline and months 6
measure: Change in visceral fat
timeFrame: Baseline and months 6
measure: Change in Systolic Blood pressure
timeFrame: Baseline and months 6
measure: Change in Diastolic Blood pressure
timeFrame: Baseline and months 6
measure: Change in blood lipids
timeFrame: Baseline and months 6
measure: Change in HbA1c
timeFrame: Baseline and months 6
measure: Change in insulin sensitivity
timeFrame: Baseline and months 6
measure: Change in β cell function
timeFrame: Baseline and months 6
measure: Change in pulse wave velocity (PWV)
timeFrame: Baseline and months 6
measure: Change in quality of life
timeFrame: Baseline and months 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
name: Huijie Zhang, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: