Type 2 Diabetes Mellitus
Conditions
Keywords
Time-restricted feeding, Type 2 diabetes mellitus
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.
Interventions
BEHAVIORALTime-restricted feeding
limit daily food intake to a period of 10 hours
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | through study completion, an average of 12 weeks |
| Mean blood glucose | through study completion, an average of 12 weeks |
| Time in range | through study completion, an average of 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight (kg) | through study completion, an average of 12 weeks | Electronic weighing scale will be used to weigh participants |
| 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 |
| 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 |
| Adverse event | through study completion, an average of 12 weeks | — |
| 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 |
Countries
China
Contacts
Primary ContactHaining Wang
Backup ContactWei Fu
Outcome results
None listed