Status:
COMPLETED
Study of the Effects of Xenin-25 in Humans With and Without Type 2 Diabetes Mellitus
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 l...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00798915
Start Date
December 1 2008
End Date
December 1 2012
Last Update
May 3 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110