Status:
COMPLETED
Xenin-25: Novel Regulator of Insulin Secretion and Beta-cell Function
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes Mellitus
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
- Ages 18-65. No minors will be studied.
- 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 (see below).
- Otherwise healthy volunteers that have impaired glucose tolerance (see below).
- Otherwise healthy volunteers with Diet Controlled T2DM (see below).
- Otherwise healthy volunteers with T2DM that take oral agents only and if the subject's pre-existing oral anti-diabetic agents can be safely discontinued for 48 hours prior to Oral Glucose Tolerance Test.
- Otherwise healthy volunteers with T2DM who do not use insulin for blood glucose control.
- Persons with HbA1c ≤ 9%.
- Women of childbearing potential must be currently taking/using a method of birth control that is acceptable to the investigators. 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 return have 8-10ml of blood drawn 25-30 days after the last Xenin infusion; to check for Xenin peptide antibodies that MAY develop. (All efforts will be made to complete this visit during study participation.
Exclusion
- \<18years of age or \>65 years of age
- Lacks cognitive ability to sign the consent \&/or follow the study directions for themselves
- Women unwilling to comply with using 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 @ home
- Volunteers with a history of Acute Pancreatitis
- 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.
- Volunteers with a history of cancer. Exception: skin cancer.
- Diabetics that have the potential to have a low blood sugar without them being aware that their blood sugar is low (hypoglycemia unawareness).
- Known heart, kidney. liver or pancreatic disease requiring medications.
- Subjects unwilling to allow the use of their own blood or the 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 :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00949663
Start Date
October 1 2009
End Date
February 1 2014
Last Update
July 22 2014
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110