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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Time-restricted feeding
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Time-restricted feeding, Type 2 diabetes mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time-restricted feeding

Arm Description

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

Outcomes

Primary Outcome Measures

HbA1c
Mean blood glucose
Time in range

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2021
Last Updated
June 20, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04841837
Brief Title
Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
Acronym
TREAT BB
Official Title
Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Time-restricted feeding, Type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted feeding
Arm Type
Experimental
Arm Description
Restrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted feeding
Intervention Description
limit daily food intake to a period of 10 hours
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
through study completion, an average of 12 weeks
Title
Mean blood glucose
Time Frame
through study completion, an average of 12 weeks
Title
Time in range
Time Frame
through study completion, an average of 12 weeks
Secondary Outcome Measure Information:
Title
Compliance of time-restricted feeding
Description
Percent of days when the participants follow 10-hours window of calorie intake
Time Frame
through study completion, an average of 12 weeks
Title
Adverse event
Time Frame
through study completion, an average of 12 weeks
Title
type and proportion of intestinal flora
Description
Collect fecal specimens, analyze the types and proportion of intestinal flora
Time Frame
through study completion, an average of 12 weeks
Title
Body weight (kg)
Description
Electronic weighing scale will be used to weigh participants
Time Frame
through study completion, an average of 12 weeks
Title
Body composition (fat and muscle mass)
Description
Body composition analyzer will be used to analyze fat and muscle mass
Time Frame
through study completion, an average of 12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haining Wang
Phone
010-82266920
Email
hainingmail@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Fu
Phone
010-82266920
Email
fuweiputh@bjmu.edu.cn
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Yang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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