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Precision Nutrition Counseling in Type 2 Diabetes Patients

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Diet education based on CGMS data
Conventional diet education
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring continuous glucose monitor, diet education, Precision nutrition

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CGMS Diet Education

Conventional Diet Education

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline

Secondary Outcome Measures

Change in fasting blood glucose level from baseline
Change in body weight from baseline
Change in waist circumference from baseline
Change in blood Triglyceride level from baseline
Change in blood High-density lipoprotein level from baseline
Change in blood Low-density lipoprotein level from baseline
Change in HOMA-IR from baseline
Change in c-peptide from baseline
Change in microbiome profile from baseline
Change in the diversity index of the gut microbiota, change in the compositions of the gut microbiota
Change in 7-point SMBG from baseline
Compliance/Satisfaction Questionnaire
Change in dietary habits, self-efficacy of diet management , and satisfaction with the education

Full Information

First Posted
February 2, 2020
Last Updated
February 9, 2020
Sponsor
Seoul National University Hospital
Collaborators
ChunLab
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1. Study Identification

Unique Protocol Identification Number
NCT04266171
Brief Title
Precision Nutrition Counseling in Type 2 Diabetes Patients
Official Title
Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
ChunLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
continuous glucose monitor, diet education, Precision nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGMS Diet Education
Arm Type
Experimental
Arm Title
Conventional Diet Education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Diet education based on CGMS data
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional diet education
Intervention Description
Control group will receive conventional diabetes diet education without CGMS data.
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline
Time Frame
0 week, 12 weeks
Secondary Outcome Measure Information:
Title
Change in fasting blood glucose level from baseline
Time Frame
0 week, 12 weeks
Title
Change in body weight from baseline
Time Frame
0 week, 12 weeks
Title
Change in waist circumference from baseline
Time Frame
0 week, 12 weeks
Title
Change in blood Triglyceride level from baseline
Time Frame
0 week, 12 weeks
Title
Change in blood High-density lipoprotein level from baseline
Time Frame
0 week, 12 weeks
Title
Change in blood Low-density lipoprotein level from baseline
Time Frame
0 week, 12 weeks
Title
Change in HOMA-IR from baseline
Time Frame
0 week, 12 weeks
Title
Change in c-peptide from baseline
Time Frame
0 week, 12 weeks
Title
Change in microbiome profile from baseline
Description
Change in the diversity index of the gut microbiota, change in the compositions of the gut microbiota
Time Frame
0 week, 12 weeks
Title
Change in 7-point SMBG from baseline
Time Frame
0 week, 12 weeks
Title
Compliance/Satisfaction Questionnaire
Description
Change in dietary habits, self-efficacy of diet management , and satisfaction with the education
Time Frame
0 week, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Joon Moon, MD
Phone
82-2-2072-1471
Email
ipleat.m@gmail.com
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD, PhD
Phone
82-2-2072-1965
Email
ymchomd@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Precision Nutrition Counseling in Type 2 Diabetes Patients

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