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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: L-glutamine; Other: No L-glutamine

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Charles Zerez, MD, PhD; Phone Number: 808-522-4000; Email: czerez@straub.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose	Change in fasting glucose	3 months and 6 months
Change in hemoglobin A1c	Change in hemoglobin A1c	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fructosamine	Change in fructosamine level	3 months and 6 months
Change in complete blood count	Change in complete blood count	3 months and 6 months
Change in blood chemistry	Change in blood chemistry	3 months and 6 months
Change in hepatic function	Chang e in hepatic function	3 months and 6 months
Change in microablbumin	Change in urine microalbumin	3 months and 6 months
Change in weight	Change in weight	3 months and 6 months
Change in waist circumference	Change in waist circumference	3 months and 6 months

Collaborators and Investigators

• Sponsor: Hawaii Pacific Health
• Investigators: Principal Investigator: Charles Zerez, MD, PhD, Straub Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2018-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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