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Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting (GIDMIR)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low glycemic index
High glycemic index
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Glycemia, Satiety, Insulin, Breakfast, Low glycemic index, High glycemic index

Eligibility Criteria

47 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus diagnosis.
  • Minimum period of six months under intensive insulin therapy.
  • Fast insulin prescription before breakfast.
  • 35 and 70 years of age.
  • BMI between 25 and 39.9 Kg/m2.
  • HbA1c less than or equal to 10 % (86mmol/mol)
  • Menopausal women under hormone replacement therapy

Exclusion Criteria:

  • Pregnant women.
  • Puerperal women.
  • Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.
  • Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Low glycemic index breakfast

    High glycemic index breakfast

    Arm Description

    Low glycemic index breakfast (GI=45)

    High glycemic index breakfast (GI=80)

    Outcomes

    Primary Outcome Measures

    Glycemia
    Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
    Satiety
    Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 23, 2016
    Last Updated
    August 25, 2016
    Sponsor
    Universidad de Valparaiso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02881164
    Brief Title
    Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting
    Acronym
    GIDMIR
    Official Title
    Effect of Glycemic Index of a Preparation on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy: Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Valparaiso

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Glycemia, Satiety, Insulin, Breakfast, Low glycemic index, High glycemic index

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low glycemic index breakfast
    Arm Type
    Experimental
    Arm Description
    Low glycemic index breakfast (GI=45)
    Arm Title
    High glycemic index breakfast
    Arm Type
    Active Comparator
    Arm Description
    High glycemic index breakfast (GI=80)
    Intervention Type
    Other
    Intervention Name(s)
    Low glycemic index
    Intervention Description
    Subjects intake a low glycemic index breakfast
    Intervention Type
    Other
    Intervention Name(s)
    High glycemic index
    Intervention Description
    Subjects intake a high glycemic index breakfast
    Primary Outcome Measure Information:
    Title
    Glycemia
    Description
    Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
    Time Frame
    -15 up to 120 minutes
    Title
    Satiety
    Description
    Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
    Time Frame
    Up to 120 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    47 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with type 2 diabetes mellitus diagnosis. Minimum period of six months under intensive insulin therapy. Fast insulin prescription before breakfast. 35 and 70 years of age. BMI between 25 and 39.9 Kg/m2. HbA1c less than or equal to 10 % (86mmol/mol) Menopausal women under hormone replacement therapy Exclusion Criteria: Pregnant women. Puerperal women. Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus. Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29072163
    Citation
    Lobos DR, Vicuna IA, Novik V, Vega CA. Effect of high and low glycemic index breakfast on postprandial metabolic parameters and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy: Controlled clinical trial. Clin Nutr ESPEN. 2017 Aug;20:12-16. doi: 10.1016/j.clnesp.2017.04.082. Epub 2017 May 11.
    Results Reference
    derived

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    Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

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