<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/NCT03817099</url>
  </required_header>
  <id_info>
    <org_study_id>MyDia-RNP study</org_study_id>
    <nct_id>NCT03817099</nct_id>
  </id_info>
  <brief_title>Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study</brief_title>
  <acronym>MyDia-RNP</acronym>
  <official_title>Effects of Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP) on Adherence, Acceptability, Efficacy Potential and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nestle Health Science</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Joslin Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiti Putra Malaysia</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>
      Ramadan fasting is an important event for Muslims. During Ramadan, all healthy Muslims are&#xD;
      asked to abstain from food and drink throughout the day and eat only during daybreak (also&#xD;
      know as Sahur in Malay/Arabic language) and after sunset (also know as Iftar in Malay/Arabic&#xD;
      language). Patients with type 2 diabetes (T2DM) can be exempted from fasting but most of them&#xD;
      do not perceive themselves as sick, and they continue to fast. With so many Muslims with&#xD;
      diabetes choosing to fast, there is an immediate need for evidence-based nutrition practice&#xD;
      guidelines. This study is conducted to determine the feasibility of implementing the Ramadan&#xD;
      Nutrition Plan named My Dia-RNP that is also incorporating diabetes-specific nutrition&#xD;
      formula on dietary adherence and acceptability in patients with type 2 diabetes mellitus. We&#xD;
      hypothesized that My Dia-RNP is feasible to be practiced by patients with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Malaysia, average fasting duration is about 14 hours which could potentially cause&#xD;
      hypoglycemia, hyperglycemia, ketoacidosis, and dehydration among people with diabetes. Also,&#xD;
      Ramadan triggers a prime dietary change leading to increased risk of nutritional issues from&#xD;
      improper eating habits and reduction in physical activity level (Hamdy et al., 2016). Ramadan&#xD;
      fasting, therefore, represents a challenge to both patients and healthcare professionals&#xD;
      (HCPs) including dietitians.&#xD;
&#xD;
      Ramadan Nutrition Plan (RNP) has recently published by the International Diabetes Federation&#xD;
      (IDF) and the Diabetes and Ramadan (DAR) International Alliance IDF-DAR guidelines. The goal&#xD;
      is to provide comprehensive guidance on nutrition practice during Ramadan. However, its&#xD;
      feasibility in the real clinical scenarios warrants further investigation.&#xD;
&#xD;
      Besides, the use of a diabetes-specific nutrition formula (Nutren Untuk Diabetik®) has been&#xD;
      shown beneficial in improving blood glucose control and managing body weight as well as&#xD;
      enhancing the nutrient adequacy among people with diabetes (Hamdy and Barakatun-Nisak 2016).&#xD;
      While the benefits have been well established, no study has explored its potential during&#xD;
      Ramadan.&#xD;
&#xD;
      Malaysia Diabetes-Ramadan Nutrition Plan (My Dia-RNP) is proposed to determine the&#xD;
      feasibility of implementing the RNP and to incorporate the diabetes-specific nutrition&#xD;
      formula (Nutren Untuk Diabetik®) during Ramadan on dietary adherence and acceptability in&#xD;
      patients with type 2 diabetes mellitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to two groups in parallel for the duration of the study based on their choice</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of participants completed the study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of participants adhered to the intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Dietary adherence refers to the ability of the participants to adhere to the selected group. This study aims to achieve the completeness of Ramadan Diaries and the able to consume diabetes-specific nutrition formula (Nutren® untuk Diabetik) for at least 75% during the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy potential on the rate of hypoglycemia</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in rate of hypoglycemia during Ramadan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy potential on the fructosamine level</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes in fructosamine levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy potential on fasting glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in fasting blood glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy potential on glycemic control</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in HbA1c levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy potential on functional status</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in hand grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy potential on body mass index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in body mass index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>My Dia-RNP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the My Dia-RNP group, participants will undergo the pre-RNP assessment 2 weeks before Ramadan. They will be given a nutrition education based on the Ramadan Nutrition Plan Guide published by IDF-DAR Practical Guidelines. They will also be asked to incorporate diabetes-specific nutrition formula (Nutren untuk Diabetik®) within the prescribed calories before Ramadan period to help them familiarise with a dietary change.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant in this group will continue in a usual care (UC) group. They will receive dietary advice based on the Practical Guide to Diabetes Management in Ramadan produced by Ministry of Health (2015).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Intervention based on My Dia-RNP</intervention_name>
    <description>Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)</description>
    <arm_group_label>My Dia-RNP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Subjects in the group continue with the usual care</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Muslim patients aged &gt; 18 years old&#xD;
&#xD;
          -  Have a confirmed diagnosis of T2D for at least 6 months&#xD;
&#xD;
          -  BMI &gt; 18.5 but &lt; 40 kg/m2&#xD;
&#xD;
          -  HbA1c of &gt; 6.5% but &lt; 10%&#xD;
&#xD;
          -  On a stabilised dose of oral anti-diabetes agents (OAD) for the past 2 months prior to&#xD;
             the study&#xD;
&#xD;
          -  Willing to fast for at least 15 days during Ramadan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypoglycaemia leading to hospitalization during the previous Ramadan&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Abnormal liver function test or renal profiles&#xD;
&#xD;
          -  On insulin injection&#xD;
&#xD;
          -  Reported abnormal thyroid stimulating hormones&#xD;
&#xD;
          -  Use of medications known to effect lipid or glucose metabolism such as steroid&#xD;
&#xD;
          -  Pregnancy or the desire to become pregnant in the next 3 months&#xD;
&#xD;
          -  On any weight loss program or weight loss medications&#xD;
&#xD;
          -  History of cancer undergoing active treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barakatun-Nisak Mohd Yusof, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wan Zul Haikal Hafiz Wan Zukiman, Mmed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Noraida Omar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zalina Abu Zaid, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azrina Azlan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Firdaus Mamat @ Mukhtar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norhasmah Sulaiman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Siti NurA'syura Adznam, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nur Maziah Hanum Osman, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nor Farahain Yahya, Degree</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osama Hamdy, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Joslin Diabetes Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barakatun-Nisak Mohd Yusof, PhD</last_name>
    <phone>03-89472524</phone>
    <phone_ext>2524</phone_ext>
    <email>bnisak@upm.edu.my</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universiti Putra Malaysia</name>
      <address>
        <city>Serdang</city>
        <state>Selangor</state>
        <zip>43400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barakatun-Nisak Mohd Yusof, PhD</last_name>
      <phone>03-89472524</phone>
      <phone_ext>2524</phone_ext>
      <email>bnisak@upm.edu.my</email>
    </contact>
    <contact_backup>
      <last_name>Barakatun-Nisak Mohd Yusof, PhD</last_name>
      <phone>0389472524</phone>
      <phone_ext>2524</phone_ext>
      <email>bnisak@upm.edu.my</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Babineaux SM, Toaima D, Boye KS, Zagar A, Tahbaz A, Jabbar A, Hassanein M. Multi-country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med. 2015 Jun;32(6):819-28. doi: 10.1111/dme.12685. Epub 2015 Apr 10.</citation>
    <PMID>25581456</PMID>
  </reference>
  <reference>
    <citation>Bujang MA, Ismail M, Hatta NKBM, Othman SH, Baharum N, Lazim SSM. Validation of the Malay version of Diabetes Quality of Life (DQOL) Questionnaire for Adult Population with Type 2 Diabetes Mellitus. Malays J Med Sci. 2017 Aug;24(4):86-96. doi: 10.21315/mjms2017.24.4.10. Epub 2017 Aug 18.</citation>
    <PMID>28951693</PMID>
  </reference>
  <reference>
    <citation>Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.</citation>
    <PMID>10987780</PMID>
  </reference>
  <reference>
    <citation>Hamdy O, Barakatun-Nisak MY. Nutrition in Diabetes. Endocrinol Metab Clin North Am. 2016 Dec;45(4):799-817. doi: 10.1016/j.ecl.2016.06.010.</citation>
    <PMID>27823606</PMID>
  </reference>
  <reference>
    <citation>Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Type 2 diabetes patient's perspective on Ramadan fasting: a qualitative study. BMJ Open Diabetes Res Care. 2017 May 8;5(1):e000365. doi: 10.1136/bmjdrc-2016-000365. eCollection 2017.</citation>
    <PMID>28761651</PMID>
  </reference>
  <reference>
    <citation>Lee SWH, Lee JY, Tan CSS, Wong CP. Strategies to Make Ramadan Fasting Safer in Type 2 Diabetics: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials and Observational Studies. Medicine (Baltimore). 2016 Jan;95(2):e2457. doi: 10.1097/MD.0000000000002457.</citation>
    <PMID>26765440</PMID>
  </reference>
  <reference>
    <citation>Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study. Sci Rep. 2017 Aug 31;7(1):10119. doi: 10.1038/s41598-017-10564-y.</citation>
    <PMID>28860546</PMID>
  </reference>
  <reference>
    <citation>Lessan N, Hannoun Z, Hasan H, Barakat MT. Glucose excursions and glycaemic control during Ramadan fasting in diabetic patients: insights from continuous glucose monitoring (CGM). Diabetes Metab. 2015 Feb;41(1):28-36. doi: 10.1016/j.diabet.2014.11.004. Epub 2014 Dec 10.</citation>
    <PMID>25497966</PMID>
  </reference>
  <reference>
    <citation>Salti I, Benard E, Detournay B, Bianchi-Biscay M, Le Brigand C, Voinet C, Jabbar A; EPIDIAR study group. A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004 Oct;27(10):2306-11. doi: 10.2337/diacare.27.10.2306.</citation>
    <PMID>15451892</PMID>
  </reference>
  <reference>
    <citation>Hassanein M, Al-Arouj M, Hamdy O, Bebakar WMW, Jabbar A, Al-Madani A, Hanif W, Lessan N, Basit A, Tayeb K, Omar M, Abdallah K, Al Twaim A, Buyukbese MA, El-Sayed AA, Ben-Nakhi A; International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical guidelines. Diabetes Res Clin Pract. 2017 Apr;126:303-316. doi: 10.1016/j.diabres.2017.03.003. Epub 2017 Mar 12.</citation>
    <PMID>28347497</PMID>
  </reference>
  <reference>
    <citation>Jadviscokova T, Fajkusova Z, Pallayova M, Luza J, Kuzmina G. Occurence of adverse events due to continuous glucose monitoring. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2007 Dec;151(2):263-6. doi: 10.5507/bp.2007.044.</citation>
    <PMID>18345261</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Putra Malaysia</investigator_affiliation>
    <investigator_full_name>Barakatun Nisak Bt Mohd Yusof</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data is subjected to privacy</ipd_description>
  </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/NCT03817099
org study id: MyDia-RNP study
nct id: NCT03817099
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ramadan fasting is an important event for Muslims. During Ramadan, all healthy Muslims are
      asked to abstain from food and drink throughout the day and eat only during daybreak (also
      know as Sahur in Malay/Arabic language) and after sunset (also know as Iftar in Malay/Arabic
      language). Patients with type 2 diabetes (T2DM) can be exempted from fasting but most of them
      do not perceive themselves as sick, and they continue to fast. With so many Muslims with
      diabetes choosing to fast, there is an immediate need for evidence-based nutrition practice
      guidelines. This study is conducted to determine the feasibility of implementing the Ramadan
      Nutrition Plan named My Dia-RNP that is also incorporating diabetes-specific nutrition
      formula on dietary adherence and acceptability in patients with type 2 diabetes mellitus. We
      hypothesized that My Dia-RNP is feasible to be practiced by patients with type 2 diabetes.
In Malaysia, average fasting duration is about 14 hours which could potentially cause
      hypoglycemia, hyperglycemia, ketoacidosis, and dehydration among people with diabetes. Also,
      Ramadan triggers a prime dietary change leading to increased risk of nutritional issues from
      improper eating habits and reduction in physical activity level (Hamdy et al., 2016). Ramadan
      fasting, therefore, represents a challenge to both patients and healthcare professionals
      (HCPs) including dietitians.

      Ramadan Nutrition Plan (RNP) has recently published by the International Diabetes Federation
      (IDF) and the Diabetes and Ramadan (DAR) International Alliance IDF-DAR guidelines. The goal
      is to provide comprehensive guidance on nutrition practice during Ramadan. However, its
      feasibility in the real clinical scenarios warrants further investigation.

      Besides, the use of a diabetes-specific nutrition formula (Nutren Untuk Diabetik®) has been
      shown beneficial in improving blood glucose control and managing body weight as well as
      enhancing the nutrient adequacy among people with diabetes (Hamdy and Barakatun-Nisak 2016).
      While the benefits have been well established, no study has explored its potential during
      Ramadan.

      Malaysia Diabetes-Ramadan Nutrition Plan (My Dia-RNP) is proposed to determine the
      feasibility of implementing the RNP and to incorporate the diabetes-specific nutrition
      formula (Nutren Untuk Diabetik®) during Ramadan on dietary adherence and acceptability in
      patients with type 2 diabetes mellitus.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to two groups in parallel for the duration of the study based on their choice
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of participants completed the study
time frame: 12 weeks
description: The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.
measure: Rate of participants adhered to the intervention
time frame: 12 weeks
description: Dietary adherence refers to the ability of the participants to adhere to the selected group. This study aims to achieve the completeness of Ramadan Diaries and the able to consume diabetes-specific nutrition formula (Nutren® untuk Diabetik) for at least 75% during the study period.
measure: Efficacy potential on the rate of hypoglycemia
time frame: 12 weeks
description: Changes in rate of hypoglycemia during Ramadan
measure: Efficacy potential on the fructosamine level
time frame: 4 weeks
description: Changes in fructosamine levels
measure: Efficacy potential on fasting glucose
time frame: 12 weeks
description: Changes in fasting blood glucose levels
measure: Efficacy potential on glycemic control
time frame: 12 weeks
description: Changes in HbA1c levels
measure: Efficacy potential on functional status
time frame: 12 weeks
description: Changes in hand grip strength
measure: Efficacy potential on body mass index
time frame: 12 weeks
description: Changes in body mass index
arm group label: My Dia-RNP
arm group type: Experimental
description: In the My Dia-RNP group, participants will undergo the pre-RNP assessment 2 weeks before Ramadan. They will be given a nutrition education based on the Ramadan Nutrition Plan Guide published by IDF-DAR Practical Guidelines. They will also be asked to incorporate diabetes-specific nutrition formula (Nutren untuk Diabetik®) within the prescribed calories before Ramadan period to help them familiarise with a dietary change.
arm group label: Usual Care
arm group type: Active Comparator
description: Participant in this group will continue in a usual care (UC) group. They will receive dietary advice based on the Practical Guide to Diabetes Management in Ramadan produced by Ministry of Health (2015).
intervention type: Other
intervention name: Nutrition Intervention based on My Dia-RNP
description: Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)
arm group label: My Dia-RNP
intervention type: Other
intervention name: Usual Care
description: Subjects in the group continue with the usual care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barakatun-Nisak Mohd Yusof, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Wan Zul Haikal Hafiz Wan Zukiman, Mmed
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Noraida Omar, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Zalina Abu Zaid, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Azrina Azlan, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Firdaus Mamat @ Mukhtar, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Norhasmah Sulaiman, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Siti NurA'syura Adznam, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Nur Maziah Hanum Osman, Master
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Nor Farahain Yahya, Degree
role: Principal Investigator
affiliation: Universiti Putra Malaysia
last name: Osama Hamdy, MD, PhD
role: Principal Investigator
affiliation: Joslin Diabetes Centre
last name: Barakatun-Nisak Mohd Yusof, PhD
phone: 03-89472524
phone ext: 2524
email: bnisak@upm.edu.my
facility: 
status: Recruiting
contact: 
contact backup: 
country: Malaysia
citation: Babineaux SM, Toaima D, Boye KS, Zagar A, Tahbaz A, Jabbar A, Hassanein M. Multi-country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med. 2015 Jun;32(6):819-28. doi: 10.1111/dme.12685. Epub 2015 Apr 10.
PMID: 25581456
citation: Bujang MA, Ismail M, Hatta NKBM, Othman SH, Baharum N, Lazim SSM. Validation of the Malay version of Diabetes Quality of Life (DQOL) Questionnaire for Adult Population with Type 2 Diabetes Mellitus. Malays J Med Sci. 2017 Aug;24(4):86-96. doi: 10.21315/mjms2017.24.4.10. Epub 2017 Aug 18.
PMID: 28951693
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responsible party type: Principal Investigator
investigator affiliation: Universiti Putra Malaysia
investigator full name: Barakatun Nisak Bt Mohd Yusof
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: The data is subjected to privacy