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

NCT ID: NCT04841837

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Time-restricted feeding

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

Group Type EXPERIMENTAL

Time-restricted feeding

Intervention Type BEHAVIORAL

limit daily food intake to a period of 10 hours

Interventions

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Time-restricted feeding

limit daily food intake to a period of 10 hours

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haining Wang

Role: CONTACT

010-82266920

Wei Fu

Role: CONTACT

010-82266920

Facility Contacts

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Kun Yang

Role: primary

Other Identifiers

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IRB00006761-M2021024

Identifier Type: -

Identifier Source: org_study_id

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