NCT04841837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

April 6, 2021

Last Update Submit

June 20, 2022

Conditions

Type 2 Diabetes Mellitus

Keywords

Time-restricted feedingType 2 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Compliance of time-restricted feeding

    through study completion, an average of 12 weeks

  • Adverse event

    through study completion, an average of 12 weeks

  • type and proportion of intestinal flora

    through study completion, an average of 12 weeks

  • Body weight (kg)

    through study completion, an average of 12 weeks

  • Body composition (fat and muscle mass)

    through study completion, an average of 12 weeks

Study Arms (1)

Time-restricted feeding

EXPERIMENTAL

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

Interventions

Time-restricted feedingBEHAVIORAL

limit daily food intake to a period of 10 hours

Time-restricted feeding

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFastingFeeding BehaviorBehavior

Central Study Contacts

Haining Wang

CONTACT

010-82266920hainingmail@bjmu.edu.cn

Wei Fu

CONTACT

010-82266920fuweiputh@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 12, 2021

Study Start

April 15, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)