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Precision Nutrition Counseling in Type 2 Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266171
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
ChunLab
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (CGMS) in longterm glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who received diet education using CGMS will be compared to those in subjects who received conventional diet education.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Diet education based on CGMS data Behavioral: Conventional diet education Not Applicable

Detailed Description:
Fifty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are CGMS education group and conventional education group. The study will be conducted for 12 weeks for each participants. Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, homeostatic model assessment of insulin resistance (HOMA-IR) , c-peptide, microbiome, 7-point self monitoring of blood glucose (SMBG), and compliance/satisfaction questionnaire from baseline for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CGMS Diet Education Behavioral: Diet education based on CGMS data
Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data.

Active Comparator: Conventional Diet Education Behavioral: Conventional diet education
Control group will receive conventional diabetes diet education without CGMS data.




Primary Outcome Measures :
  1. Change in HbA1c from baseline [ Time Frame: 0 week, 12 weeks ]

Secondary Outcome Measures :
  1. Change in fasting blood glucose level from baseline [ Time Frame: 0 week, 12 weeks ]
  2. Change in body weight from baseline [ Time Frame: 0 week, 12 weeks ]
  3. Change in waist circumference from baseline [ Time Frame: 0 week, 12 weeks ]
  4. Change in blood Triglyceride level from baseline [ Time Frame: 0 week, 12 weeks ]
  5. Change in blood High-density lipoprotein level from baseline [ Time Frame: 0 week, 12 weeks ]
  6. Change in blood Low-density lipoprotein level from baseline [ Time Frame: 0 week, 12 weeks ]
  7. Change in HOMA-IR from baseline [ Time Frame: 0 week, 12 weeks ]
  8. Change in c-peptide from baseline [ Time Frame: 0 week, 12 weeks ]
  9. Change in microbiome profile from baseline [ Time Frame: 0 week, 12 weeks ]
    Change in the diversity index of the gut microbiota, change in the compositions of the gut microbiota

  10. Change in 7-point SMBG from baseline [ Time Frame: 0 week, 12 weeks ]
  11. Compliance/Satisfaction Questionnaire [ Time Frame: 0 week, 12 weeks ]
    Change in dietary habits, self-efficacy of diet management , and satisfaction with the education



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes patients (Fasting blood glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin)
  • HbA1c 6.5%~10%
  • Body weight change less than 5% in 3 month
  • Subjects who agreed to the study protocol

Exclusion Criteria:

  • Type 1 diabetes patients
  • Subjects using insulin other than basal insulin
  • Subjects who have newly started or have changed anti diabetic drugs within 3 months
  • Subjects who have been received diabetes diet education within 6 months
  • Females who are pregnant or doing breast feeding
  • Subjects with alcohol addiction or drug abuse
  • Subjects who are using drugs that can influence blood glucose levels (e.g. steroid)
  • Subjects who are currently using acetaminophen or who should use acetaminophen during CGMS attach period
  • Subjects who have skin problems on CGMS sensor insertion site (e.g. burn, excessive body hair, inflammation, rash, tattoo)
  • Subjects who have newly started, changed, or stoped probiotics or prebiotics within 2 weeks
  • Subjects who have used antibiotics (oral or intravenous) within 2 weeks
  • In addition, if it falls under the exclusion criteria according to researchers discretion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266171


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sun Joon Moon, MD    82-2-2072-1471    ipleat.m@gmail.com   
Contact: Young Min Cho, MD, PhD    82-2-2072-1965    ymchomd@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
ChunLab

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04266171    
Other Study ID Numbers: H-1911-059-1078
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
continuous glucose monitor
diet education
Precision nutrition
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases