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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04841837
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.5
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Time-restricted feeding	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Apr 15, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Time-restricted feeding Restrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity	Behavioral: Time-restricted feeding; limit daily food intake to a period of 10 hours

Outcome Measures

Primary Outcome Measures

1. HbA1c [through study completion, an average of 12 weeks]

2. Mean blood glucose [through study completion, an average of 12 weeks]

3. Time in range [through study completion, an average of 12 weeks]

Secondary Outcome Measures

1. 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

2. Adverse event [through study completion, an average of 12 weeks]

3. 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

4. Body weight (kg) [through study completion, an average of 12 weeks]

   Electronic weighing scale will be used to weigh participants

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing		China

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04841837
• Other Study ID Numbers: IRB00006761-M2021024
• First Posted: Apr 12, 2021
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: Time-restricted feeding; Type 2 diabetes mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 22, 2022