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GIP: Glucose-Dependent Insulinotropic Peptide

This study is ongoing, but not recruiting participants.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  GIP: Glucose-Dependent Insulinotropic Peptide
Official Title  Effect of GIP / GIP Analog in Type 2 Diabetes After a Meal
Brief Summary

The purpose of this study is to test the safety of glucose-dependent insulinotropic peptide (GIP)/GIP Analog on people with Type 2 Diabetes.

Detailed Description

The small bowel makes a hormone called glucose-dependent insulinotropic peptide (GIP). It is released into the blood stream and goes to the pancreas. It works there with nutrients, especially glucose, in the digested food so that insulin is released in sufficient amounts from the pancreas. The insulin causes the nutrients from the food to be stored in the liver, fat and muscle until they are needed to provide energy. GIP also slows emptying of food from the stomach, which decreases the rate with which fats in food are broken down and stored. Once it is released into the blood, GIP is quickly broken down and becomes inactive. Individuals with type 2 diabetes do not make enough GIP and pharmacological doses of naturally occurring GIP do not increase insulin secretion in patients with type 2 diabetes. This study is testing a modified GIP (it had one amino acid difference from naturally occurring human GIP) that is not broken down as quickly in individuals with type 2 diabetes, to determine if it will improve insulin secretion, after eating, in patients with type 2 diabetes. The study will also compare its effects to that of naturally occurring, human GIP. Both human GIP and the modified GIP (GIP analog) are manufactured by peptide synthesis techniques (not extracted from human gut and not recombinant technology).

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure  GIP, glucose, insulin measured frequently during infusions at baseline, 2 months, and 4 months
Secondary Outcome Measure  GLP-1, ghrelin measured frequently during infusions at baseline, 2 months, and 4 months
Condition  Type 2 Diabetes
Intervention  Drug: GIP and GIP Analog
MEDLINE PMIDs 464094,   8423228,   8036284
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  24
Start Date  February 2003
Completion Date July 2006
Eligibility Criteria 

Inclusion Criteria:

  • 18 years of age and older
  • 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:

  • Taking the following medications: Insulin, or Thiazolidinediones, i.e. Avandia, Actos
  • Pregnancy
  • Steroid use within the past 3 months
  • Recent infection, fever or chills
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00239707
Organization ID AG0056
Secondary IDs ††
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Josephine Egan, MD     Chief, Diabetes Section, National Institute on Aging    
Information Provided By National Institute on Aging (NIA)
Verification Date November 2006
First Received Date  October 13, 2005
Last Updated Date November 9, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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