<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03802253</url>
  </required_header>
  <id_info>
    <org_study_id>KYH2019-001</org_study_id>
    <nct_id>NCT03802253</nct_id>
  </id_info>
  <brief_title>Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)</brief_title>
  <acronym>TRIG</acronym>
  <official_title>Study to Evaluate the Effects of Time-Restricted Feeding Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Xiamen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We evaluated the effects of Time-Restricted Feeding (TRF) regimen on Impaired Glucose&#xD;
      Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over&#xD;
      12 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 18, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in HbA1c level (%)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum fasting insulin levels (pmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of regression to normoglycaemia among the studied population</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight (Kilograms)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference (cm)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index (kg/m2)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic pressure (mmHg)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diastolic pressure (mmHg）</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting blood glucose (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in β cell function</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>β cell function will be assessed by HOMA-β</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>Insulin sensitivity will be assessed by HOMA-IR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum total cholesterol levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum low density lipoprotein cholesterol levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum triglyceride levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum high density lipoprotein cholesterol levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum alanine aminotransferase levels levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum aspartate aminotransferase levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum gamma glutamyltranspeptidase levels (mmol/L)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in controlled attenuation parameter(dB/m)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Changes in liver fibrosis</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Epworth sleepiness scores（ESS)</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in depressive symptoms</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Time-Restricted Feeding</condition>
  <condition>Impaired Glucose Regulation</condition>
  <condition>Overweight/Obese</condition>
  <arm_group>
    <arm_group_label>TRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RCD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will focus on standard care with daily reduced calorie diet (RCD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time Restricted Feeding(TRF)</intervention_name>
    <description>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 feeding time.</description>
    <arm_group_label>TRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reduced Calorie Diet (RCD)</intervention_name>
    <description>Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.</description>
    <arm_group_label>RCD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥ 18 year&#xD;
&#xD;
          2. Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired&#xD;
             glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by&#xD;
             latest OGTT results within 3 months prior to recruitment&#xD;
&#xD;
          3. Body mass index (BMI)of 23.0 to 45.0 kg/m2;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of DM or on hypoglycaemic treatment&#xD;
&#xD;
          2. Women who are pregnant or breast-feeding at recruitment&#xD;
&#xD;
          3. Patients taking glucocorticoid at recruitment&#xD;
&#xD;
          4. Active and uncontrolled thyroid diseases (including subjects on thyroid replacement&#xD;
             therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome&#xD;
             or Acromegaly at recruitment&#xD;
&#xD;
          5. Serious liver dysfunction or chronic kidney disease (AST or ALT &gt; 3 times the upper&#xD;
             limit of normal, or eGFR&lt;30 ml/min/1.73 m2);&#xD;
&#xD;
          6. History of serious cardiovascular or cerebrovascular disease (angina, myocardial&#xD;
             infarction or stroke) in the past 6 months;&#xD;
&#xD;
          7. Taking medications affecting weight or energy intake/energy expenditure in the last 6&#xD;
             months, including weight loss medications, antipsychotic drugs or other medications as&#xD;
             determined by the study physician;&#xD;
&#xD;
          8. Currently participating in weight loss programs or weight change in the past 3 months&#xD;
             (&gt; 5% current body weight) ;&#xD;
&#xD;
          9. Patients who cannot be followed for 24 months (due to a health situation or&#xD;
             migration);&#xD;
&#xD;
         10. Patients who are unwilling or unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Changqin Liu, MD&amp;PhD</last_name>
    <phone>+8613376986106</phone>
    <phone_ext>+8613376986106</phone_ext>
    <email>liuchangqin@xmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xin zheng, MD</last_name>
    <phone>+8618705929102</phone>
    <email>88126386@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of Xiamen university</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changqin Liu, MD</last_name>
      <phone>+86-133 7698 6106</phone>
      <email>liuchangqin@xmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>August 19, 2023</last_update_submitted>
  <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802253
org study id: KYH2019-001
nct id: NCT03802253
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We evaluated the effects of Time-Restricted Feeding (TRF) regimen on Impaired Glucose
      Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over
      12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Changes in HbA1c level (%)
time frame: 3 months, 6 months and 12 months
measure: Change in serum fasting insulin levels (pmol/L)
time frame: 3 months, 6 months and 12 months
measure: Incidence of regression to normoglycaemia among the studied population
time frame: 12 months
measure: Changes in body weight (Kilograms)
time frame: 3 months, 6 months and 12 months
measure: Changes in waist circumference (cm)
time frame: 3 months, 6 months and 12 months
measure: Change in body mass index (kg/m2)
time frame: 3 months, 6 months and 12 months
measure: Changes in systolic pressure (mmHg)
time frame: 3 months, 6 months and 12 months
measure: Changes in diastolic pressure (mmHg）
time frame: 3 months, 6 months and 12 months
measure: Changes in fasting blood glucose (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Change in β cell function
time frame: 3 months, 6 months and 12 months
description: β cell function will be assessed by HOMA-β
measure: Change in insulin sensitivity
time frame: 3 months, 6 months and 12 months
description: Insulin sensitivity will be assessed by HOMA-IR
measure: Changes in serum total cholesterol levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in serum low density lipoprotein cholesterol levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in serum triglyceride levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in serum high density lipoprotein cholesterol levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in serum alanine aminotransferase levels levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in serum aspartate aminotransferase levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in serum gamma glutamyltranspeptidase levels (mmol/L)
time frame: 3 months, 6 months and 12 months
measure: Changes in controlled attenuation parameter(dB/m)
time frame: 3 months, 6 months and 12 months
description: Controlled attenuation parameter will be assessed by transient elastography (FibroScan(®) ）
measure: Changes in Changes in liver fibrosis
time frame: 3 months, 6 months and 12 months
description: Liver fibrosis will be assessed by transient elastography (FibroScan(®) ）
measure: Changes in Epworth sleepiness scores（ESS)
time frame: 3 months, 6 months and 12 months
description: The range of epworth sleepiness scores（ESS) is from 0 to 24 and higher scores mean worse outcome.
measure: Changes in depressive symptoms
time frame: 3 months, 6 months and 12 months
description: 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.
arm group label: TRF
arm group type: Experimental
description: Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
arm group label: RCD
arm group type: Active Comparator
description: Participants in this group will focus on standard care with daily reduced calorie diet (RCD)
intervention type: Behavioral
intervention name: Time Restricted Feeding(TRF)
description: 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 feeding time.
arm group label: TRF
intervention type: Behavioral
intervention name: Reduced Calorie Diet (RCD)
description: Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
arm group label: RCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Changqin Liu, MD&PhD
phone: +8613376986106
phone ext: +8613376986106
email: liuchangqin@xmu.edu.cn
last name: Xin zheng, MD
phone: +8618705929102
email: 88126386@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Overweight