Type 2 Diabetes MellitusTREAT BBNCT04841837
Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
A study testing Time-restricted feeding in people with Type 2 Diabetes Mellitus, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Time-restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Kun Yang
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Time-restricted feeding
- Keywords
- Time-restricted feeding, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted feedingBehavioural
limit daily food intake to a period of 10 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Time-restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: through study completion, an average of 12 weeks
Mean blood glucose
Measured: through study completion, an average of 12 weeks
Time in range
Measured: through study completion, an average of 12 weeks
Secondary outcomes (5)
Compliance of time-restricted feeding
Percent of days when the participants follow 10-hours window of calorie intake
Measured: through study completion, an average of 12 weeks
Adverse event
Measured: through study completion, an average of 12 weeks
type and proportion of intestinal flora
Collect fecal specimens, analyze the types and proportion of intestinal flora
Measured: through study completion, an average of 12 weeks
Body weight (kg)
Electronic weighing scale will be used to weigh participants
Measured: through study completion, an average of 12 weeks
Body composition (fat and muscle mass)
Body composition analyzer will be used to analyze fat and muscle mass
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start15 Apr 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841837
- Sponsor's protocol ID
- IRB00006761-M2021024
- Acronym
- TREAT BB
- Status last verified
- Jun 2022
- First submitted
- 6 Apr 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04841837
- Acronym / sponsor ID
- TREAT BB / IRB00006761-M2021024
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Time-restricted feeding, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time-restricted feeding | Experimental | Behavioral: Time-restricted feedingRestrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted feedinglimit daily food intake to a period of 10 hours | Behavioural | Time-restricted feeding |
Primary outcome
HbA1c
Time frame: through study completion, an average of 12 weeks
Mean blood glucose
Time frame: through study completion, an average of 12 weeks
Time in range
Time frame: through study completion, an average of 12 weeks
5 secondary outcomes
Compliance of time-restricted feeding
Time frame: through study completion, an average of 12 weeks
Adverse event
Time frame: through study completion, an average of 12 weeks
type and proportion of intestinal flora
Time frame: through study completion, an average of 12 weeks
Body weight (kg)
Time frame: through study completion, an average of 12 weeks
Body composition (fat and muscle mass)
Time frame: through study completion, an average of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted feeding in people with Type 2 Diabetes Mellitus, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haining Wang (010-82266920, hainingmail@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: through study completion, an average of 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.