Precision Nutrition Counseling in Type 2 Diabetes Patients

Seoul National University

Status

Unknown

Conditions

Type 2 Diabetes

Treatments

Behavioral: Conventional diet education

Behavioral: Diet education based on CGMS data

Study type

Interventional

Funder types

Other

Identifiers

NCT04266171

H-1911-059-1078

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No 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