Completed

#6113Influence of MATE1 and OCT3 Genetic Variants on Metformin Response in African Americans with Type 2 Diabetes

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Study Aim

This study aims to evaluate how genetic variants of transporters OCT3 and MATE1 affect the glucose lowering response and pharmacokinetics of metformin in African Americans with Type 2 Diabetes.

What is being tested

Metformin

Drug
Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: February 2010
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: October 23, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2010

Actual date on which the first participant was enrolled.

To investigate the potential association of polymorphic genetic variants MATE1 and OCT3 with altered response to metformin, a genotype to phenotype strategy is employed. Specifically, the investigators will evaluate this hypothesis in African-Americans, a population which has a high incidence of type 2 diabetes and which has high variant allele frequencies (44.5% for MATE1-66T>C and 11.3% in OCT3-81G>delGA) relative to other ethic groups. To assess the effects of these variants on metformin response, the investigators will measure metformin renal clearance (pharmacokinetics of metformin), and plasma glucose and insulin levels (pharmacodynamic response) in healthy and diabetic patients who carry either the reference or variant alleles.

NCT01681693
Principal SponsorUniversity of California, San Francisco
Last updated: October 23, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 2

Criteria

5 inclusion criteria required to participate
Subject status is healthy volunteer from t In the event that diabetes is indicated in a normal subject based on OGTT results, we will notify the patients' primary care physician. he SOPHIE cohort OR diagnosis of T2DM based on American Diabetes Association (ADA) criteria
Subjects over 18 years old and below 60 years
Subjects self-identify racial background, identify themselves, parents and four grandparents as African American
Subjects who agree with the written informed consent to participate in the study
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12 exclusion criteria prevent from participating
Evidence of anemia (hemoglobin < 10 g)
Has a prior history of renal* or hepatic dysfunction (renal and hepatic function will be evaluated based on screening blood tests conducted prior to study enrollment)
Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
Impaired hepatic function ( > 1.5 times the upper limit of normal)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will be given an oral dose of metformin once per day for two days.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

San Francisco General Hospital

San Francisco, United StatesOpen San Francisco General Hospital in Google Maps
CompletedOne Study Center