Clinical trial NCT03947879: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in fasting glucose
timeFrame: 3 months and 6 months
measure: Change in hemoglobin A1c
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Change in fructosamine
timeFrame: 3 months and 6 months
measure: Change in complete blood count
timeFrame: 3 months and 6 months
measure: Change in blood chemistry
timeFrame: 3 months and 6 months
measure: Change in hepatic function
timeFrame: 3 months and 6 months
measure: Change in microablbumin
timeFrame: 3 months and 6 months
measure: Change in weight
timeFrame: 3 months and 6 months
measure: Change in waist circumference
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Straub Medical Center
name: Charles Zerez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: