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NCT03947879 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03947879
Other study ID # 2018-119
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 2019
Est. completion date May 2022

Study information
Verified date May 2019
Source Hawaii Pacific Health
Contact Charles Zerez, MD, PhD
Phone 808-522-4000
Email czerez@straub.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date May 2022
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• L-glutamine
15 g of L-glutamine twice daily by mouth for 3 months.
Other:
• No L-glutamine
The same patients will be given no L-glutamine for 3 months.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hawaii Pacific Health

Outcome
Type Measure Description Time frame Safety issue
Primary Change in fasting glucose Change in fasting glucose 3 months and 6 months
Primary Change in hemoglobin A1c Change in hemoglobin A1c 3 months and 6 months
Secondary Change in fructosamine Change in fructosamine level 3 months and 6 months
Secondary Change in complete blood count Change in complete blood count 3 months and 6 months
Secondary Change in blood chemistry Change in blood chemistry 3 months and 6 months
Secondary Change in hepatic function Chang e in hepatic function 3 months and 6 months
Secondary Change in microablbumin Change in urine microalbumin 3 months and 6 months
Secondary Change in weight Change in weight 3 months and 6 months
Secondary Change in waist circumference Change in waist circumference 3 months and 6 months
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