Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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Diet management could improve blood and weight control in patients with diabetes mellitus. Time-restricted feeding is a novel dietary tool that limits time of energy intake without altering diet quality or quantity. This study aims to assess the effect of 10-hour time-restricted feeding on metabolism and behavior in patients with type 2 diabetes mellitus.

Official Title
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Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Time-restricted feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes mellitus HbA1c 7.0% to 8.5% BMI ≥ 24 kg/m2 Time of energy intake ≥ 12 hours per day, ≥ 4 days per week Ability to use smart phone and app, to follow study protocol Sign informed consent Exclusion Criteria: Use insulin, long-acting insulin secretagogues, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor Suffer from disease influence eating: mental disease, subtotal gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease Work state affect eating time: constant night duty, constant long-haul international travel Smoking Drinking Severe disease: severe cardiovascular and cerebrovascular disease, uncontrolled arrhythmia, heart failure, acute and chronic renal dysfunction, liver cirrhosis, malignancy, anemia Suffered from infectious disease: pulmonary tuberculosis, AIDS Dyskinesia Body weight change ≥ 5 kg in the past 3 months Hospitalized in the past 3 months Used antibiotics for ≥ 3 days in the past 3 months Diagnosed with type 1 diabetes mellitus Pregnancy, lactating Participating in other clinical trials in the past 1 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-restricted feeding<br>Restrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity | Behavioral: Time-restricted feeding<br>* limit daily food intake to a period of 10 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | through study completion, an average of 12 weeks | 
| Mean blood glucose |  | through study completion, an average of 12 weeks | 
| Time in range |  | through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of time-restricted feeding | Percent of days when the participants follow 10-hours window of calorie intake | through study completion, an average of 12 weeks | 
| Adverse event |  | through study completion, an average of 12 weeks | 
| type and proportion of intestinal flora | Collect fecal specimens, analyze the types and proportion of intestinal flora | through study completion, an average of 12 weeks | 
| Body weight (kg) | Electronic weighing scale will be used to weigh participants | through study completion, an average of 12 weeks | 
| Body composition (fat and muscle mass) | Body composition analyzer will be used to analyze fat and muscle mass | through study completion, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time-restricted feeding, Type 2 diabetes mellitus