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

Type 2 Diabetes Mellitus Clinical Trial

— TREAT BB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04841837
• Other study ID #: IRB00006761-M2021024
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: Peking University Third Hospital
• Contact: Haining Wang
• Phone: 010-82266920
• Email: hainingmail[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Time-restricted feeding
limit daily food intake to a period of 10 hours

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		through study completion, an average of 12 weeks
Primary	Mean blood glucose		through study completion, an average of 12 weeks
Primary	Time in range		through study completion, an average of 12 weeks
Secondary	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
Secondary	Adverse event		through study completion, an average of 12 weeks
Secondary	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
Secondary	Body weight (kg)	Electronic weighing scale will be used to weigh participants	through study completion, an average of 12 weeks
Secondary	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