NCT03947879

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started May 2019

Longer than P75 for phase_1 diabetes-mellitus-type-2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

April 17, 2019

Last Update Submit

May 10, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Change in fasting glucose

    Change in fasting glucose

    3 months and 6 months

  • Change in hemoglobin A1c

    Change in hemoglobin A1c

    3 months and 6 months

Secondary Outcomes (7)

  • Change in fructosamine

    3 months and 6 months

  • Change in complete blood count

    3 months and 6 months

  • Change in blood chemistry

    3 months and 6 months

  • Change in hepatic function

    3 months and 6 months

  • Change in microablbumin

    3 months and 6 months

  • +2 more secondary outcomes

Study Arms (2)

L-glutamine

EXPERIMENTAL

Treatment with L-glutamine for 3 months.

Drug: L-glutamine

No L-glutamine

EXPERIMENTAL

No L-glutamine for 3 months.

Other: No L-glutamine

Interventions

L-glutamineDRUG

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

Also known as: Endari
L-glutamine
No L-glutamineOTHER

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

No L-glutamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of diabetes mellitus type II
  • Patient of Straub Medical Center, Internal Medicine Clinic

You may not qualify if:

  • Renal and liver impairment ( GFR less than 40)
  • Transaminitis (elevation of AST of ALT more than 2 fold)
  • Patient with sickle cell anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Charles Zerez, MD, PhD

    Straub Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Zerez, MD, PhD

CONTACT

808-522-4000czerez@straub.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Physician

Study Record Dates

First Submitted

April 17, 2019

First Posted

May 13, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2022

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share