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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: L-glutamine
* Other: No L-glutamine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-glutamine<br>Treatment with L-glutamine for 3 months. | Drug: L-glutamine<br>* 15 g of L-glutamine twice daily by mouth for 3 months.<br>* Other names: Endari;|
| Experimental: No L-glutamine<br>No L-glutamine for 3 months. | Other: No L-glutamine<br>* The same patients will be given no L-glutamine for 3 months.<br>|

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 |