Clinical trial NCT04266171: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitor
diet education
Precision nutrition
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: ChunLab
First posted: 2020-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 0 week, 12 weeks
Secondary outcomes:
measure: Change in fasting blood glucose level from baseline
timeFrame: 0 week, 12 weeks
measure: Change in body weight from baseline
timeFrame: 0 week, 12 weeks
measure: Change in waist circumference from baseline
timeFrame: 0 week, 12 weeks
measure: Change in blood Triglyceride level from baseline
timeFrame: 0 week, 12 weeks
measure: Change in blood High-density lipoprotein level from baseline
timeFrame: 0 week, 12 weeks
measure: Change in blood Low-density lipoprotein level from baseline
timeFrame: 0 week, 12 weeks
measure: Change in HOMA-IR from baseline
timeFrame: 0 week, 12 weeks
measure: Change in c-peptide from baseline
timeFrame: 0 week, 12 weeks
measure: Change in microbiome profile from baseline
timeFrame: 0 week, 12 weeks
measure: Change in 7-point SMBG from baseline
timeFrame: 0 week, 12 weeks
measure: Compliance/Satisfaction Questionnaire
timeFrame: 0 week, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: