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Influence of Preprandial Metformin Administration on Carbohydrate Absorption (METTIME)

Primary Purpose

Impaired Glucose Tolerance, Type2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral glucose tolerance test (OGTT) with or without metformin
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Impaired glucose tolerance, type 2 diabetes, obesity, carbohydrate absorption, metformin

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Obesity (BMI ≥30 kg/m2)
  • Dysglycemia (HbA1c≥ 6,0 %)
  • No anti diabetic medication

Exclusion Criteria:

  • No obesity (BMI < 30 kg/m2)
  • No dysglycemia (HbA1c <6,0%)
  • Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids)
  • Anemia (Hb <12 g/dL)
  • Organ failure
  • Inflammatory Bowel Disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    taking metformin 30 or 60 minutes before the OGTT

    No metformin before OGTT

    Arm Description

    Outcomes

    Primary Outcome Measures

    Area under the curve of D-Xylose

    Secondary Outcome Measures

    Number of Participants with gastrointestinal side effects
    Area under the curve of blood glucose
    Area under the curve of insulin
    Area under the curve of GLP-1

    Full Information

    First Posted
    July 10, 2019
    Last Updated
    August 18, 2022
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04018105
    Brief Title
    Influence of Preprandial Metformin Administration on Carbohydrate Absorption
    Acronym
    METTIME
    Official Title
    Influence of Preprandial Metformin Administration on Carbohydrate Absorption: Pilot Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption. It is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake. To study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impaired Glucose Tolerance, Type2 Diabetes
    Keywords
    Impaired glucose tolerance, type 2 diabetes, obesity, carbohydrate absorption, metformin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    taking metformin 30 or 60 minutes before the OGTT
    Arm Type
    Experimental
    Arm Title
    No metformin before OGTT
    Arm Type
    Placebo Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Oral glucose tolerance test (OGTT) with or without metformin
    Intervention Description
    Each participant will have 3 OGTT, one without metformin, one with metformin30 minutes before the test, one with metformin 60 minutes before the test. The order for each test will be randomized.
    Primary Outcome Measure Information:
    Title
    Area under the curve of D-Xylose
    Time Frame
    During the 3 hours OGTT
    Secondary Outcome Measure Information:
    Title
    Number of Participants with gastrointestinal side effects
    Time Frame
    During the 3 hours OGTT
    Title
    Area under the curve of blood glucose
    Time Frame
    During the 3 hours OGTT
    Title
    Area under the curve of insulin
    Time Frame
    During the 3 hours OGTT
    Title
    Area under the curve of GLP-1
    Time Frame
    During the 3 hours OGTT

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Obesity (BMI ≥30 kg/m2) Dysglycemia (HbA1c≥ 6,0 %) No anti diabetic medication Exclusion Criteria: No obesity (BMI < 30 kg/m2) No dysglycemia (HbA1c <6,0%) Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids) Anemia (Hb <12 g/dL) Organ failure Inflammatory Bowel Disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Camille Marciniak, MD
    Phone
    03.20.44.67.37
    Ext
    +33
    Email
    camille.marciniak@chru-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    camille Marciniak, MD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Influence of Preprandial Metformin Administration on Carbohydrate Absorption

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