| Trial ID: | L3340 |
| Source ID: | NCT02548741
|
| Associated Drug: |
Metformin Hydrochloride (500-Mg Capsule)
|
| Title: |
Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes
|
| Acronym: |
MET
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Metformin Hydrochloride (500-mg capsule)|DRUG: Calcium carbonate (placebo)|OTHER: Glucometer (One Touch glucometer), strips and lancets|OTHER: Urine container for 24-hour urine collection
|
| Outcome Measures: |
Primary: Plasma methylglyoxal (MG) concentration (μM), Investigators will measure MG concentration at baseline and after 6 weeks of metformin administration. An increase in MG has been associated with type-2 diabetes and progression of diabetes complications. Metformin is a known scavenger of MG, forming a metformin-MG imidazolinone (IMZ) cyclized product. This unique property of metformin in enhanced reduction of diabetic complications may be related to its MG-scavenging capabilities. Investigators will measure the concentrations of MG in the human plasma of the cohort in the μM range via mass spectrometry. Investigators will be normalizing these values by specific gravity., Change from baseline in plasma MG concentration at 6 weeks of metformin administration | Secondary: The urine imidazolinone (IMZ) concentration (nM), Metformin is a known scavenger of MG, forming a metformin-MG imidazolinone (IMZ) cyclized product. This unique property of metformin in enhanced reduction of diabetic complications may be related to its MG-scavenging capabilities. Investigators will measure the IMZ concentration/content at baseline and after 6 weeks of metformin administration. Investigators hypothesized that a concomitant elevation in urine IMZ concentration/content is associated with metformin administration. Investigators will measure the concentrations of IMZ in the human urine plasma of the cohort in the nM range via mass spectrometry. Investigators will be normalizing these values by specific gravity., Change from baseline in urine IMZ concentration at 6 weeks of metformin administration
|
| Sponsor/Collaborators: |
Sponsor: University of Arizona
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09
|
| Completion Date: |
2017-08
|
| Results First Posted: |
|
| Last Update Posted: |
2015-09-14
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02548741
|
