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The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
L-glutamine
No L-glutamine
Sponsored by
Hawaii Pacific Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of diabetes mellitus type II
  • Patient of Straub Medical Center, Internal Medicine Clinic

Exclusion Criteria:

  • Renal and liver impairment ( GFR less than 40)
  • Transaminitis (elevation of AST of ALT more than 2 fold)
  • Patient with sickle cell anemia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    L-glutamine

    No L-glutamine

    Arm Description

    Treatment with L-glutamine for 3 months.

    No L-glutamine for 3 months.

    Outcomes

    Primary Outcome Measures

    Change in fasting glucose
    Change in fasting glucose
    Change in hemoglobin A1c
    Change in hemoglobin A1c

    Secondary Outcome Measures

    Change in fructosamine
    Change in fructosamine level
    Change in complete blood count
    Change in complete blood count
    Change in blood chemistry
    Change in blood chemistry
    Change in hepatic function
    Chang e in hepatic function
    Change in microablbumin
    Change in urine microalbumin
    Change in weight
    Change in weight
    Change in waist circumference
    Change in waist circumference

    Full Information

    First Posted
    April 17, 2019
    Last Updated
    May 10, 2019
    Sponsor
    Hawaii Pacific Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03947879
    Brief Title
    The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II
    Official Title
    The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2019 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hawaii Pacific Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is an initial non-blinded, non-placebo controlled trial to determine the efficacy of L-glutamine in lowering blood sugar in patients with diabetes mellitus type II without sickle cell anemia.
    Detailed Description
    The protocol will consist of starting patients on 15 g of L glutamine twice daily by mouth. This is the same dose that is used to treat patient with sickle cell anemia. They will be given this medication for a total of 3 months. Their other medications will remain the same. At the conclusion of the 3 months, the patients will be taken off of the glutamine and will continue their other medications. The investigators will monitor the patients an additional 3 months (6 months after the initiation of the study) off the L-glutamine. In this manner, the investigators will have a washout period. The outcome will be a comparison of the results before the initiation of the L-glutamine, to the results after treatment, and after the washout. Data analysis will consist of comparing the patient's fasting glucose and hemoglobin A1c values. The investigators will also check the levels of fructosamine. This is a standard test that is done in any clinical laboratory. To help determine the mechanism for the L-glutamine effect, the investigators will also measure the complete blood count, chemistry panel, hepatic function panel, urine micro-albumin, patients' weight, and waist circumference. The investigators will use the Student t-test for statistical analysis. Significance will be tested at the 0.05 level. The investigators will collect demographic information on the patients in the study. Age, sex, duration of diabetes, smoking history, and race will be noted. The investigators will use regression analysis to determine whether these factors have any effects on the observed results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    L-glutamine
    Arm Type
    Experimental
    Arm Description
    Treatment with L-glutamine for 3 months.
    Arm Title
    No L-glutamine
    Arm Type
    Experimental
    Arm Description
    No L-glutamine for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    L-glutamine
    Other Intervention Name(s)
    Endari
    Intervention Description
    15 g of L-glutamine twice daily by mouth for 3 months.
    Intervention Type
    Other
    Intervention Name(s)
    No L-glutamine
    Intervention Description
    The same patients will be given no L-glutamine for 3 months.
    Primary Outcome Measure Information:
    Title
    Change in fasting glucose
    Description
    Change in fasting glucose
    Time Frame
    3 months and 6 months
    Title
    Change in hemoglobin A1c
    Description
    Change in hemoglobin A1c
    Time Frame
    3 months and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in fructosamine
    Description
    Change in fructosamine level
    Time Frame
    3 months and 6 months
    Title
    Change in complete blood count
    Description
    Change in complete blood count
    Time Frame
    3 months and 6 months
    Title
    Change in blood chemistry
    Description
    Change in blood chemistry
    Time Frame
    3 months and 6 months
    Title
    Change in hepatic function
    Description
    Chang e in hepatic function
    Time Frame
    3 months and 6 months
    Title
    Change in microablbumin
    Description
    Change in urine microalbumin
    Time Frame
    3 months and 6 months
    Title
    Change in weight
    Description
    Change in weight
    Time Frame
    3 months and 6 months
    Title
    Change in waist circumference
    Description
    Change in waist circumference
    Time Frame
    3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of diabetes mellitus type II Patient of Straub Medical Center, Internal Medicine Clinic Exclusion Criteria: Renal and liver impairment ( GFR less than 40) Transaminitis (elevation of AST of ALT more than 2 fold) Patient with sickle cell anemia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charles Zerez, MD, PhD
    Phone
    808-522-4000
    Email
    czerez@straub.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Zerez, MD, PhD
    Organizational Affiliation
    Straub Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II

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