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

Hawaii Pacific Health

Status and phase: Unknown; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: L-glutamine; Other: No L-glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03947879

2018-119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

L-glutamine

Experimental group

Description:

Treatment with L-glutamine for 3 months.

Treatment:

Drug: L-glutamine

No L-glutamine

Experimental group

Description:

No L-glutamine for 3 months.

Treatment:

Other: No L-glutamine