Impaired Glucose RegulationTRIGNCT03802253
Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)
A study testing Time Restricted eating(TRE) and Reduced Calorie Diet (RCD) in people with Impaired Glucose Regulation and Overweight/Obese, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Impaired Glucose Regulation, Overweight/Obese, Time-restricted Eating
- What is being tested?
- Time Restricted eating(TRE) and Reduced Calorie Diet (RCD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged ≥ 18 year
- Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment
- Body mass index (BMI)of 23.0 to 45.0 kg/m2;
Who cannot join
- Confirmed diagnosis of DM or on hypoglycaemic treatment
- Women who are pregnant or breast-feeding at recruitment
- Patients taking glucocorticoid at recruitment
- Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
- Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
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- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Patients who are unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Xiamen university
Xiamen, Fujian, 361003
About this study
Official title: Study to Evaluate the Effects of Time-Restricted Eating Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.
- Being tested
- Time Restricted eating(TRE), Reduced Calorie Diet (RCD)
- Medical subject headings
- Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted eating(TRE)Behavioural
Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later, Participants will receive a diet of 1200-1500kcal/d without a restriction of eating time.
Reduced Calorie Diet (RCD)Behavioural
Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
| Study group | Role | What they receive |
|---|---|---|
| TRE | Experimental | Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction. Receives: Behavioral: Time Restricted eating(TRE) |
| RCD | Active comparator | Participants in this group will focus on standard care with daily reduced calorie diet (RCD) Receives: Behavioral: Reduced Calorie Diet (RCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of regression to normoglycaemia among the studied population
Measured: 12 months
Secondary outcomes (22)
Incidence of impaired glucose regulation progressing to diabetes
Incidence of impaired glucose regulation progressing to diabetes
Measured: 12 months
Changes in body weight (Kilograms)
Measured: 3 months, 6 months and 12 months
Changes in waist circumference (cm)
Measured: 3 months, 6 months and 12 months
Change in body mass index (kg/m2)
Measured: 3 months, 6 months and 12 months
Changes in systolic pressure (mmHg)
Measured: 3 months, 6 months and 12 months
Changes in diastolic pressure (mmHg）
Measured: 3 months, 6 months and 12 months
Changes in fasting blood glucose (mmol/L)
Measured: 3 months, 6 months and 12 months
Change in β cell function
β cell function will be assessed by HOMA-β
Measured: 3 months, 6 months and 12 months
Change in insulin sensitivity
Insulin sensitivity will be assessed by HOMA-IR
Measured: 3 months, 6 months and 12 months
Changes in serum total cholesterol levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in serum triglyceride levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in serum alanine aminotransferase levels levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in serum aspartate aminotransferase levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in serum gamma glutamyltranspeptidase levels (mmol/L)
Measured: 3 months, 6 months and 12 months
Changes in Changes in liver fibrosis
Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）
Measured: 3 months, 6 months and 12 months
Changes in controlled attenuation parameter(dB/m)
Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）
Measured: 3 months, 6 months and 12 months
Changes in Epworth sleepiness scores（ESS)
The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.
Measured: 3 months, 6 months and 12 months
Changes in depressive symptoms
Depressive symptoms will be assessed by Patient Health Questionnaire-9 (PHQ-9) algorithm scoring method. The range of PHQ-9 is from 0 to 27 and higher scores mean worse outcome.
Measured: 3 months, 6 months and 12 months
Changes in HbA1c level (%)
Measured: Time Frame: 3 months, 6 months and 12 months
Change in serum fasting insulin levels (pmol/L)
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start4 May 2020
- Primary completion31 Aug 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose RegulationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802253
- Sponsor's protocol ID
- KYH2019-001
- Acronym
- TRIG
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effects of Time-Restricted Eating Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
- ClinicalTrials.gov ID
- NCT03802253
- Acronym / sponsor ID
- TRIG / KYH2019-001
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Jan 2019 (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.
We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRE | Experimental | Behavioral: Time Restricted eating(TRE)Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction. |
| RCD | Active comparator | Behavioral: Reduced Calorie Diet (RCD)Participants in this group will focus on standard care with daily reduced calorie diet (RCD) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 18 year
- Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment
- Body mass index (BMI)of 23.0 to 45.0 kg/m2;
Key exclusion criteria (10 listed)
- Confirmed diagnosis of DM or on hypoglycaemic treatment
- Women who are pregnant or breast-feeding at recruitment
- Patients taking glucocorticoid at recruitment
- Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
- Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
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 eating(TRE)Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later, Participants will receive a diet of 1200-1500kcal/d without a restriction of eating time. | Behavioural | TRE |
| Reduced Calorie Diet (RCD)Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern. | Behavioural | RCD |
Primary outcome
Incidence of regression to normoglycaemia among the studied population
Time frame: 12 months
22 secondary outcomes
Incidence of impaired glucose regulation progressing to diabetes
Time frame: 12 months
Changes in body weight (Kilograms)
Time frame: 3 months, 6 months and 12 months
Changes in waist circumference (cm)
Time frame: 3 months, 6 months and 12 months
Change in body mass index (kg/m2)
Time frame: 3 months, 6 months and 12 months
Changes in systolic pressure (mmHg)
Time frame: 3 months, 6 months and 12 months
Changes in diastolic pressure (mmHg）
Time frame: 3 months, 6 months and 12 months
Changes in fasting blood glucose (mmol/L)
Time frame: 3 months, 6 months and 12 months
Change in β cell function
Time frame: 3 months, 6 months and 12 months
Change in insulin sensitivity
Time frame: 3 months, 6 months and 12 months
Changes in serum total cholesterol levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in serum low density lipoprotein cholesterol levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in serum triglyceride levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in serum high density lipoprotein cholesterol levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in serum alanine aminotransferase levels levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in serum aspartate aminotransferase levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in serum gamma glutamyltranspeptidase levels (mmol/L)
Time frame: 3 months, 6 months and 12 months
Changes in Changes in liver fibrosis
Time frame: 3 months, 6 months and 12 months
Changes in controlled attenuation parameter(dB/m)
Time frame: 3 months, 6 months and 12 months
Changes in Epworth sleepiness scores（ESS)
Time frame: 3 months, 6 months and 12 months
Changes in depressive symptoms
Time frame: 3 months, 6 months and 12 months
Changes in HbA1c level (%)
Time frame: Time Frame: 3 months, 6 months and 12 months
Change in serum fasting insulin levels (pmol/L)
Time frame: 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Impaired Glucose Regulation, Impaired Glucose Tolerance (Prediabetes)
Not yet recruiting
Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control
Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus
Not yet recruitingPhase 4
Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 eating(TRE) and Reduced Calorie Diet (RCD) in people with Impaired Glucose Regulation and Overweight/Obese, run by The First Affiliated Hospital of Xiamen University 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of regression to normoglycaemia among the studied population (time frame: 12 months). 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 13 Apr 2026.