## Protocol Section
### Identification Module
**NCT ID:** NCT03947879

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2018-119
#### Organization
**Class:** OTHER
**Full Name:** Hawaii Pacific Health
### Status Module
#### Completion Date
**Date:** 2022-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2019-05-13

**Type:** ACTUAL

**Last Update Submit Date:** 2019-05-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-05

**Type:** ESTIMATED

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2019-05-13
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-17
**Study First Submit QC Date:** 2019-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hawaii Pacific Health

#### Responsible Party

**Investigator Affiliation:** Hawaii Pacific Health

**Investigator Full Name:** Charles R Zerez, PhD, MD

**Investigator Title:** Internal Medicine Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment with L-glutamine for 3 months.

**Intervention Names:**

- Drug: L-glutamine

**Label:** L-glutamine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No L-glutamine for 3 months.

**Intervention Names:**

- Other: No L-glutamine

**Label:** No L-glutamine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- L-glutamine

**Description:** 15 g of L-glutamine twice daily by mouth for 3 months.

**Name:** L-glutamine

**Other Names:**

- Endari

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- No L-glutamine

**Description:** The same patients will be given no L-glutamine for 3 months.

**Name:** No L-glutamine

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Change in fasting glucose

**Measure:** Change in fasting glucose

**Time Frame:** 3 months and 6 months

**Description:** Change in hemoglobin A1c

**Measure:** Change in hemoglobin A1c

**Time Frame:** 3 months and 6 months

#### Secondary Outcomes

**Description:** Change in fructosamine level

**Measure:** Change in fructosamine

**Time Frame:** 3 months and 6 months

**Description:** Change in complete blood count

**Measure:** Change in complete blood count

**Time Frame:** 3 months and 6 months

**Description:** Change in blood chemistry

**Measure:** Change in blood chemistry

**Time Frame:** 3 months and 6 months

**Description:** Chang e in hepatic function

**Measure:** Change in hepatic function

**Time Frame:** 3 months and 6 months

**Description:** Change in urine microalbumin

**Measure:** Change in microablbumin

**Time Frame:** 3 months and 6 months

**Description:** Change in weight

**Measure:** Change in weight

**Time Frame:** 3 months and 6 months

**Description:** Change in waist circumference

**Measure:** Change in waist circumference

**Time Frame:** 3 months and 6 months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** czerez@straub.net

**Name:** Charles Zerez, MD, PhD

**Phone:** 808-522-4000

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Straub Medical Center

**Name:** Charles Zerez, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Browse Branches

- Abbrev: AA

- Name: Amino Acids

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T6

- Name: Glutamine

- Relevance: HIGH

- As Found: Bladder Cancer

### Misc Info Module

- Version Holder: 2024-05-24
