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Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arginyl-fructose
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes focused on measuring Anti-hyperglycemic effect

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL.

Exclusion Criteria:

- Exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    TEST

    Placebo

    Arm Description

    Arginyl-fructose Supplementation

    Placebo Supplementation

    Outcomes

    Primary Outcome Measures

    2-h oral glucose tolerance tests (OGTTs

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2014
    Last Updated
    November 5, 2014
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02285231
    Brief Title
    Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-diabetes
    Keywords
    Anti-hyperglycemic effect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TEST
    Arm Type
    Experimental
    Arm Description
    Arginyl-fructose Supplementation
    Arm Title
    Placebo
    Arm Type
    Experimental
    Arm Description
    Placebo Supplementation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Arginyl-fructose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    2-h oral glucose tolerance tests (OGTTs
    Time Frame
    6 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL. Exclusion Criteria: - Exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26578409
    Citation
    Park SE, Kim OH, Kwak JH, Lee KH, Kwon YI, Chung KH, Lee JH. Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial. Trials. 2015 Nov 14;16:521. doi: 10.1186/s13063-015-1036-z.
    Results Reference
    derived

    Learn more about this trial

    Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.

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