Precision Nutrition Counseling in Type 2 Diabetes Patients
9. februar 2020 opdateret af: Seoul National University Hospital
Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
-
Seoul, Korea, Republikken
- Rekruttering
- Seoul National University Hospital
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Kontakt:
- Sun Joon Moon, MD
- Telefonnummer: 82-2-2072-1471
- E-mail: ipleat.m@gmail.com
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Kontakt:
- Young Min Cho, MD, PHD
- Telefonnummer: 82-2-2072-1965
- E-mail: ymchomd@snu.ac.kr
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 79 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CGMS Diet Education
|
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.
|
|
Aktiv komparator: Conventional Diet Education
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Control group will receive conventional diabetes diet education without CGMS data.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in HbA1c from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in fasting blood glucose level from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in body weight from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in waist circumference from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in blood Triglyceride level from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in blood High-density lipoprotein level from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in blood Low-density lipoprotein level from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in HOMA-IR from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in c-peptide from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Change in microbiome profile from baseline
Tidsramme: 0 week, 12 weeks
|
Change in the diversity index of the gut microbiota, change in the compositions of the gut microbiota
|
0 week, 12 weeks
|
|
Change in 7-point SMBG from baseline
Tidsramme: 0 week, 12 weeks
|
0 week, 12 weeks
|
|
|
Compliance/Satisfaction Questionnaire
Tidsramme: 0 week, 12 weeks
|
Change in dietary habits, self-efficacy of diet management , and satisfaction with the education
|
0 week, 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. januar 2020
Primær færdiggørelse (Forventet)
31. december 2021
Studieafslutning (Forventet)
31. december 2021
Datoer for studieregistrering
Først indsendt
2. februar 2020
Først indsendt, der opfyldte QC-kriterier
9. februar 2020
Først opslået (Faktiske)
12. februar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. februar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-1911-059-1078
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