<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/NCT04463277</url>
  </required_header>
  <id_info>
    <org_study_id>IFCR-186</org_study_id>
    <nct_id>NCT04463277</nct_id>
  </id_info>
  <brief_title>A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients</brief_title>
  <official_title>Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients With Prediabetes and Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Usman Bin Hameed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research aims to find an effective dietary intervention among the Pakistani population.&#xD;
      According to WHO, diabetes is on the rise in developing countries; the current prevalence&#xD;
      among the Pakistani population is 11.2% which is expected to increase in the coming years&#xD;
      which is in line with the similar documented trend in neighboring south Asian countries.3,11&#xD;
      Since, ethnic south Asians carry a greater risk for developing T2D at a younger age and along&#xD;
      with the complications associated with diabetes due to its chronicity, this poses a&#xD;
      significant threat and an increased disease burden on the health care system.11&#xD;
&#xD;
      This will be the first trial conducted on determining the efficacy of caloric restriction in&#xD;
      a subset of Pakistani population. There is limited inconsistent data on the efficacy of&#xD;
      time-restricted feeding, however, this will help elucidate if it does lead to positive&#xD;
      effects on the bio-health markers. One of the major hurdles in caloric restriction is patient&#xD;
      compliance, therefore, one of the intervention group will be used to determine if TRF with&#xD;
      caloric restriction helps improve the patient's compliance and produces significant results.&#xD;
      If such an intervention is effective in inducing weight loss it can also be applied for other&#xD;
      overweight patients. Eventually, it will help in countering the rising obesity in the region.&#xD;
&#xD;
      The ultimate purpose of the knowledge obtained is to find a patient friendly, novel and&#xD;
      therapeutic dietary intervention which will help in limiting the rise in T2D patients. It'll&#xD;
      help in introducing an effective lifestyle intervention to promote health, which will reduce&#xD;
      the dependence on pharmacological therapies, as well as, in the long-term reduce burden on&#xD;
      the health care system.&#xD;
&#xD;
      The information obtained can provide framework for new guidelines in helping the patients to&#xD;
      lose weight, which can be utilized by the government to increase general awareness which will&#xD;
      help prevent diseases linked to obesity. In light of the randomized controlled trial, the&#xD;
      primary health physicians can educate and increase awareness regarding the different dietary&#xD;
      interventions the patients can utilize which will help increase the number of options for the&#xD;
      patients. Social media platforms can be utilized due to their extended outreach for the&#xD;
      transmission of accurate information to the general population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">May 15, 2021</completion_date>
  <primary_completion_date type="Actual">May 15, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in participants' weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FBS</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in participants' fasting plasma glucose levels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OGTT</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in participants' response to an oral glucose load.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Lipid Profile.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Calorie Restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Time Restricted Feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Time Restricted Feeding with Calorie Restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Calorie Restriction</intervention_name>
    <description>Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.</description>
    <arm_group_label>Calorie Restriction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time Restricted Feeding</intervention_name>
    <description>Participants assigned to this arm to consume food at maintenance calories (calories required per day to maintain weight, calculated based on height, weight and physical activity using the MyFitnessPal application) within an 8-hour window during daylight hours.</description>
    <arm_group_label>Time Restricted Feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time Restricted Feeding with Calorie Restriction</intervention_name>
    <description>Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day within an 8-hour window during daylight hours.</description>
    <arm_group_label>Time Restricted Feeding with Calorie Restriction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Glycemic values belonging to diabetes or prediabetes category.&#xD;
&#xD;
          -  Weight stable for at least 6 months prior to start of study.&#xD;
&#xD;
          -  Ability to understand English and use English language mobile applications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Diabetics taking insulin or sulfonylureas.&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  History of cardiovascular disease.&#xD;
&#xD;
          -  History of psychiatric or eating disorders.&#xD;
&#xD;
          -  History of hypoglycemic episodes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Nadeem, M.B.B.S, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Aga Khan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Aga Khan University Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>June 6, 2021</last_update_submitted>
  <last_update_submitted_qc>June 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Usman Bin Hameed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463277
org study id: IFCR-186
nct id: NCT04463277
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research aims to find an effective dietary intervention among the Pakistani population.
      According to WHO, diabetes is on the rise in developing countries; the current prevalence
      among the Pakistani population is 11.2% which is expected to increase in the coming years
      which is in line with the similar documented trend in neighboring south Asian countries.3,11
      Since, ethnic south Asians carry a greater risk for developing T2D at a younger age and along
      with the complications associated with diabetes due to its chronicity, this poses a
      significant threat and an increased disease burden on the health care system.11

      This will be the first trial conducted on determining the efficacy of caloric restriction in
      a subset of Pakistani population. There is limited inconsistent data on the efficacy of
      time-restricted feeding, however, this will help elucidate if it does lead to positive
      effects on the bio-health markers. One of the major hurdles in caloric restriction is patient
      compliance, therefore, one of the intervention group will be used to determine if TRF with
      caloric restriction helps improve the patient's compliance and produces significant results.
      If such an intervention is effective in inducing weight loss it can also be applied for other
      overweight patients. Eventually, it will help in countering the rising obesity in the region.

      The ultimate purpose of the knowledge obtained is to find a patient friendly, novel and
      therapeutic dietary intervention which will help in limiting the rise in T2D patients. It'll
      help in introducing an effective lifestyle intervention to promote health, which will reduce
      the dependence on pharmacological therapies, as well as, in the long-term reduce burden on
      the health care system.

      The information obtained can provide framework for new guidelines in helping the patients to
      lose weight, which can be utilized by the government to increase general awareness which will
      help prevent diseases linked to obesity. In light of the randomized controlled trial, the
      primary health physicians can educate and increase awareness regarding the different dietary
      interventions the patients can utilize which will help increase the number of options for the
      patients. Social media platforms can be utilized due to their extended outreach for the
      transmission of accurate information to the general population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight
time frame: 12 weeks
description: Change in participants' weight.
measure: FBS
time frame: 12 weeks
description: Change in participants' fasting plasma glucose levels.
measure: HbA1c
time frame: 12 weeks
description: Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.
measure: OGTT
time frame: 12 weeks
description: Change in participants' response to an oral glucose load.
measure: Serum Lipid Profile.
time frame: 12 weeks
description: Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.
arm group label: Calorie Restriction
arm group type: Experimental
arm group label: Time Restricted Feeding
arm group type: Experimental
arm group label: Time Restricted Feeding with Calorie Restriction
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Calorie Restriction
description: Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.
arm group label: Calorie Restriction
intervention type: Behavioral
intervention name: Time Restricted Feeding
description: Participants assigned to this arm to consume food at maintenance calories (calories required per day to maintain weight, calculated based on height, weight and physical activity using the MyFitnessPal application) within an 8-hour window during daylight hours.
arm group label: Time Restricted Feeding
intervention type: Behavioral
intervention name: Time Restricted Feeding with Calorie Restriction
description: Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day within an 8-hour window during daylight hours.
arm group label: Time Restricted Feeding with Calorie Restriction
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sarah Nadeem, M.B.B.S, M.D.
role: Principal Investigator
affiliation: The Aga Khan University Hospital
facility: 
country: Pakistan
responsible party type: Sponsor-Investigator
investigator affiliation: Aga Khan University
investigator full name: Usman Bin Hameed
investigator title: Principal Investigator
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No