Diabetes Mellitus, Type 2Phase 1NCT03947879
The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II
A Phase 1 study testing L-glutamine and No L-glutamine in people with Diabetes Mellitus, Type 2, run by Hawaii Pacific Health.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- L-glutamine and No L-glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2019to May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of diabetes mellitus type II
- Patient of Straub Medical Center, Internal Medicine Clinic
Who cannot join
- Renal and liver impairment ( GFR less than 40)
- Transaminitis (elevation of AST of ALT more than 2 fold)
- Patient with sickle cell anemia
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Diabetes Mellitus, Type 2
- Being tested
- L-glutamine, No L-glutamine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-glutamineDrug
Also called Endari
15 g of L-glutamine twice daily by mouth for 3 months.
No L-glutamineOther
The same patients will be given no L-glutamine for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| L-glutamine | Experimental | Treatment with L-glutamine for 3 months. Receives: Drug: L-glutamine |
| No L-glutamine | Experimental | No L-glutamine for 3 months. Receives: Other: No L-glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting glucose
Change in fasting glucose
Measured: 3 months and 6 months
Change in hemoglobin A1c
Change in hemoglobin A1c
Measured: 3 months and 6 months
Secondary outcomes (7)
Change in fructosamine
Change in fructosamine level
Measured: 3 months and 6 months
Change in complete blood count
Change in complete blood count
Measured: 3 months and 6 months
Change in blood chemistry
Change in blood chemistry
Measured: 3 months and 6 months
Change in hepatic function
Chang e in hepatic function
Measured: 3 months and 6 months
Change in microablbumin
Change in urine microalbumin
Measured: 3 months and 6 months
Change in weight
Change in weight
Measured: 3 months and 6 months
Change in waist circumference
Change in waist circumference
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles R Zerez, PhD, MD, Hawaii Pacific Health
- Investigators
- Charles Zerez, MD, PhD, Principal investigator, Straub Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947879
- Sponsor's protocol ID
- 2018-119
- Status last verified
- May 2019
- First submitted
- 17 Apr 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II
- ClinicalTrials.gov ID
- NCT03947879
- Acronym / sponsor ID
- 2018-119
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hawaii Pacific HealthUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-glutamine | Experimental | Drug: L-glutamineTreatment with L-glutamine for 3 months. |
| No L-glutamine | Experimental | Other: No L-glutamineNo L-glutamine for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of diabetes mellitus type II
- Patient of Straub Medical Center, Internal Medicine Clinic
Key exclusion criteria (3 listed)
- Renal and liver impairment ( GFR less than 40)
- Transaminitis (elevation of AST of ALT more than 2 fold)
- Patient with sickle cell anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-glutamineAlso: Endari15 g of L-glutamine twice daily by mouth for 3 months. | Drug | L-glutamine |
| No L-glutamineThe same patients will be given no L-glutamine for 3 months. | Other | No L-glutamine |
Primary outcome
Change in fasting glucose
Time frame: 3 months and 6 months
Change in fasting glucose
Change in hemoglobin A1c
Time frame: 3 months and 6 months
Change in hemoglobin A1c
7 secondary outcomes
Change in fructosamine
Time frame: 3 months and 6 months
Change in complete blood count
Time frame: 3 months and 6 months
Change in blood chemistry
Time frame: 3 months and 6 months
Change in hepatic function
Time frame: 3 months and 6 months
Change in microablbumin
Time frame: 3 months and 6 months
Change in weight
Time frame: 3 months and 6 months
Change in waist circumference
Time frame: 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Zerez, MD, PhD principal investigator
Straub Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-glutamine and No L-glutamine in people with Diabetes Mellitus, Type 2, run by Hawaii Pacific Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Zerez, MD, PhD (808-522-4000, czerez@straub.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting glucose (time frame: 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.