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Saint Louis, Missouri 63110


An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released into the blood immediately after ingestion of a meal and plays an important role in regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This study is being conducted to determine whether a hormone called xenin-25 can restore the activity of GIP in persons with T2DM.

Study summary:

Each eligible participant will be administered an oral glucose tolerance test so he/she can be assigned to the group with "normal glucose tolerance", "impaired glucose tolerance" (between normal and diabetic), or type 2 diabetes mellitus. Each study subject will then be administered a graded glucose infusion (GGI) on 4 separate occasions. For the GGI, an intravenous glucose infusion will be started at a rate of 1 mg x kg-1 x min-1 for 40 min, followed by 2, 3, 4, 6, and 8 mg x kg-1 x min-1 (40 min for each step). A primed-continuous infusion of vehicle alone, GIP alone, xenin-25 alone, or the combination of GIP plus xenin-25 (each peptide at a dose of 4 pmoles x kg-1 x min-1) will be initiated at the same time the glucose infusion is started. Blood samples will be collected before and during the GGI for the measurement of glucose, insulin, C-peptide, glucagon, GIP and xenin-25 levels.


Inclusion Criteria: - Individuals must be able to consent for their own participation (no mental impairment affecting cognition or willingness to follow study instructions). - Healthy volunteers with no clinical evidence of T2DM. - Otherwise healthy volunteers that have impaired glucose tolerance. - Otherwise healthy volunteers with diet controlled T2DM. - Otherwise healthy volunteers with T2DM that take oral agents only if the subject's pre-existing oral anti-diabetic agents can be safely discontinued for 48-hours. - Persons with HbA1c less than 9%. - Women of childbearing potential must be currently taking/using an acceptable method of birth control. A pregnancy test will be done at the beginning of each visit. Any woman with a positive pregnancy test will be removed from the study. - Willingness to complete all required visits. Exclusion Criteria: - Lacks cognitive ability to sign the consent or follow the study directions. - Women unwilling to use an acceptable method of contraception during the course of the study, or who are currently breast-feeding. - Any subject whose screening HbA1c is >9.0%. - Type 2 diabetes requiring the use of supplemental insulin at home. - Volunteers with a history of Acute Pancreatitis. - Volunteers with a history of cancer (except for skin cancer). - Volunteer with a history of Chronic Pancreatitis and/or risk factors for chronic pancreatitis including hypertriglyceridemia (triglycerides >400mg/ml) hypercalcemia (blood calcium level >11.md/dl) and/or the presence of gallstones. - Volunteers with a history of gastrointestinal disorders, particularly related to gastric motility/emptying such as gastric bypass, documented gastro-paresis in diabetic volunteers. - Subjects taking medications known to affect glucose tolerance. - Hematocrit from the lab is below 33% (or if the finger stick hemoglobin measured with the HemoCue 201+ is <11.2% mg/dlL). - Diabetics that have the potential to have a low blood sugar without them being aware that their blood sugar is low (hypoglycemia unawareness). - Significant systemic illness including heart, kidney, inflammatory, liver, or malignant disease requiring medications. - Subjects will be excluded if their liver or kidney function is outside the upper limits of normal by > 3%. Total Bilirubin levels should be <2. - Subjects unwilling to allow the use of human albumin in the preparation of the peptides. - Unwillingness to allow blood glucose level adjustment (if needed) with IV insulin



Primary Contact:

Principal Investigator
Dominic Reeds, MD
Washington University School of Medicine

Backup Contact:


Location Contact:

Saint Louis, Missouri 63110
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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