Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2003-02-28
2006-12-31
Brief Summary
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Detailed Description
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A screening visit will be performed including blood work, EKG and physical exam. If eligible, patients would be scheduled for three infusion visits 2 months apart, where they will receive a normal saline infusion on the first visit and GIP or GIP analog on the remaining visits. The infusion visits will begin approximately 6:45 a.m. and patients will have frequent blood sampling through an intravenous line over a period of 7 hours. An additional intravenous line will be placed for the infusion of either the normal saline, GIP or GIP analog over a period of 3 hours. Patients will be given a breakfast meal consisting of 550 calories (one egg, piece of toast with margarine, corn flakes 2% milk and a banana). They will be given 2 Extra-Strength Tylenol to determine time frame that food is emptied from stomach by measuring Tylenol levels in the blood. At the end of each study visit, patients will be given lunch, intravenous lines will be discontinued and they will be discharged to home.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Infusion 1
Normal Saline
GIP
One-time 20 ng/kg/min infusion over 3 hours
Infusion 2
GIP or modified GIP
Modified GIP
One-time infusion over 3 hours; dose to maintain desired biological effect of below 140 mg/dl
Infusion 3
GIP or modified GIP, opposite of Infusion 2
Normal Saline
one-time infusion over 3 hours
Interventions
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GIP
One-time 20 ng/kg/min infusion over 3 hours
Modified GIP
One-time infusion over 3 hours; dose to maintain desired biological effect of below 140 mg/dl
Normal Saline
one-time infusion over 3 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy Type 2 Diabetics
* Agree to stay off glucosidases for 3 days prior to infusion visits (Examples: Precose, Glyset)
* Agree to stay off Sulfonylureas 5 days prior to infusion visits (Examples: Glucotrol, Amaryl, glyburide, metformin
* Able to ingest 1000 mg Tylenol on study visits
* Able to consume study breakfast consisting of scrambled egg, white toast with margarine, corn flakes, 2% milk, banana at each infusion visit
* Female participants must have Hct \> 36
* Male participant must have Hct \> 38
* No kidney or liver disease per history and evidenced by blood and urine tests
* Physical Exam and EKG that do not contraindicate patient to be in the study
Exclusion Criteria
* Pregnancy
* Steroid use within the past 3 months
* Recent infection, fever or chills
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Responsible Party
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Principal Investigators
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Josephine Egan, MD
Role: PRINCIPAL_INVESTIGATOR
Chief, Diabetes Section, National Institute on Aging
Locations
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National Institute on Aging, Clinical Research Branch
Baltimore, Maryland, United States
Countries
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References
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Elahi D, Andersen DK, Brown JC, Debas HT, Hershcopf RJ, Raizes GS, Tobin JD, Andres R. Pancreatic alpha- and beta-cell responses to GIP infusion in normal man. Am J Physiol. 1979 Aug;237(2):E185-91. doi: 10.1152/ajpendo.1979.237.2.E185. No abstract available.
Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993 Jan;91(1):301-7. doi: 10.1172/JCI116186.
Elahi D, McAloon-Dyke M, Fukagawa NK, Meneilly GS, Sclater AL, Minaker KL, Habener JF, Andersen DK. The insulinotropic actions of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (7-37) in normal and diabetic subjects. Regul Pept. 1994 Apr 14;51(1):63-74. doi: 10.1016/0167-0115(94)90136-8.
Chia CW, Odetunde JO, Kim W, Carlson OD, Ferrucci L, Egan JM. GIP contributes to islet trihormonal abnormalities in type 2 diabetes. J Clin Endocrinol Metab. 2014 Jul;99(7):2477-85. doi: 10.1210/jc.2013-3994. Epub 2014 Apr 8.
Other Identifiers
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AG0056
Identifier Type: -
Identifier Source: org_study_id