Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)
This trial is active, not recruiting.
|Sponsor||Johns Hopkins University|
|Collaborator||Merck Sharp & Dohme Corp.|
|Start date||March 2009|
|End date||May 2010|
|Trial size||64 participants|
|Trial identifier||NCT00947011, NA_00018441|
This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
|Primary purpose||health services research|
Insulin release and hepatic glucose production rate.
time frame: One year
Peripheral glucose utilization and glucagon release
time frame: one year
Male or female participants from 21 years up to 75 years old.
Inclusion Criteria: - Hct level of at least 34% for women and 36% for men - Women of non-bearing potential and women of childbearing potential using adequate contraception - Serum creatine level of less than 1.7 mg/dl - Four groups: - Age 21-45 (BMI between 18.50-24.99) & (BMI between 30-35) - Age greater than 65 years (BMI between 18.50-24.99) & (BMI between 30-35) Exclusion Criteria: - Pregnant and/or lactating females - Women of childbearing potential not willing to use adequate contraception - Hct below inclusion criteria - Serum creatine level greater than 1.8 mg/dl - Age less than 21 and age between 46-64 - Diabetes mellitus - BMI less than 18 and BMI greater than 35
|Official title||The Effect of Dipeptidyl Peptidase-4 Inhibition on GLP-1 Induced Insulin Secretion and Glucose Turnover During Mild Stable Hyperglycemia in Young and Old Normal Volunteers|
|Principal investigator||Dariush Elahi, PhD|
|Description||The purpose of the present proposal is to 1) examine the role of DPP-4 inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elevated plasma glucose levels the effect of increased active incretin levels with DPP-4 inhibitors should result in increased plasma insulin levels. Therefore the aim of this protocol is to document whether plasma insulin levels are increased following GLP-1 infusion in the presence or absence of DPP-4 inhibitors. Additionally, we have shown that some improvement in glucose homeostasis during GLP-1 administration is due in part to the metabolite of GLP-1, i.e. GLP-1 (9-36) amide (GLP-1m). Therefore, we will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.|
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