Precision Nutrition Counseling in Type 2 Diabetes Patients

STATUS

Recruiting
participants needed

50
sponsor

Seoul National University Hospital

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Updated on 19 February 2024

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fasting

nutrition education

continuous glucose monitoring

fasting blood glucose

exclusion diet

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.

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.

Details

Condition	NIDDM, Diabetes Mellitus
Age	18years - 79years
Treatment	Diet education based on CGMS data, Conventional diet education
Clinical Study Identifier	NCT04266171
Sponsor	Seoul National University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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Precision Nutrition Counseling in Type 2 Diabetes Patients