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

Peking University

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Time-restricted feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT04841837

IRB00006761-M2021024

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Time-restricted feeding

Experimental group

Description:

Restrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity

Treatment:

Behavioral: Time-restricted feeding