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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Time-restricted feeding

• Registration Number: NCT04841837
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-12
• Study Start: 2021-04-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Diagnosed with type 2 diabetes mellitus
2. HbA1c 7.0% to 8.5%
3. BMI ≥ 24 kg/m2
4. Time of energy intake ≥ 12 hours per day, ≥ 4 days per week
5. Ability to use smart phone and app, to follow study protocol
6. Sign informed consent

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Exclusion Criteria

1. Use insulin, long-acting insulin secretagogues, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor
2. Suffer from disease influence eating: mental disease, subtotal gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease
3. Work state affect eating time: constant night duty, constant long-haul international travel
4. Smoking
5. Drinking
6. Severe disease: severe cardiovascular and cerebrovascular disease, uncontrolled arrhythmia, heart failure, acute and chronic renal dysfunction, liver cirrhosis, malignancy, anemia
7. Suffered from infectious disease: pulmonary tuberculosis, AIDS
8. Dyskinesia
9. Body weight change ≥ 5 kg in the past 3 months
10. Hospitalized in the past 3 months
11. Used antibiotics for ≥ 3 days in the past 3 months
12. Diagnosed with type 1 diabetes mellitus
13. Pregnancy, lactating
14. Participating in other clinical trials in the past 1 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time-restricted feeding	Time-restricted feeding	Restrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity

Primary Outcome Measures

Name	Time	Method
Mean blood glucose	through study completion, an average of 12 weeks
HbA1c	through study completion, an average of 12 weeks
Time in range	through study completion, an average of 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China