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

Sponsor
Hawaii Pacific Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT03947879
Collaborator
(none)
25
2
36

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II
Anticipated Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-glutamine

Treatment with L-glutamine for 3 months.

Drug: L-glutamine
15 g of L-glutamine twice daily by mouth for 3 months.
Other Names:
  • Endari
  • Experimental: No L-glutamine

    No L-glutamine for 3 months.

    Other: No L-glutamine
    The same patients will be given no L-glutamine for 3 months.

    Outcome Measures

    Primary Outcome Measures

    1. Change in fasting glucose [3 months and 6 months]

      Change in fasting glucose

    2. Change in hemoglobin A1c [3 months and 6 months]

      Change in hemoglobin A1c

    Secondary Outcome Measures

    1. Change in fructosamine [3 months and 6 months]

      Change in fructosamine level

    2. Change in complete blood count [3 months and 6 months]

      Change in complete blood count

    3. Change in blood chemistry [3 months and 6 months]

      Change in blood chemistry

    4. Change in hepatic function [3 months and 6 months]

      Chang e in hepatic function

    5. Change in microablbumin [3 months and 6 months]

      Change in urine microalbumin

    6. Change in weight [3 months and 6 months]

      Change in weight

    7. Change in waist circumference [3 months and 6 months]

      Change in waist circumference

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hawaii Pacific Health

    Investigators

    • Principal Investigator: Charles Zerez, MD, PhD, Straub Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles R Zerez, PhD, MD, Internal Medicine Physician, Hawaii Pacific Health
    ClinicalTrials.gov Identifier:
    NCT03947879
    Other Study ID Numbers:
    • 2018-119
    First Posted:
    May 13, 2019
    Last Update Posted:
    May 13, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2019