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GIP: Glucose-Dependent Insulinotropic Peptide
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00239707
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Glucose-dependent insulinotropic peptide (GIP)
Drug: Modified GIP (GIP analog)
Drug: Normal Saline
Phase I

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Dextrose Benzocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Effect of GIP / GIP Analog in Type 2 Diabetes After a Meal

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • GIP, glucose, insulin measured frequently during infusions [ Time Frame: baseline, 2 months, and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GLP-1, ghrelin measured frequently during infusions [ Time Frame: baseline, 2 months, and 4 months ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2003
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Glucose-dependent insulinotropic peptide (GIP)
One-time 20 ng/kg/min infusion over 3 hours
2: Experimental Drug: Modified GIP (GIP analog)
One-time infusion over 3 hours; dose to maintain desired biological effect of below 140 mg/dl
3: Placebo Comparator Drug: Normal Saline
one-time infusion over 3 hours

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239707

Locations
United States, Maryland
National Institute on Aging, Clinical Research Branch
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: Josephine Egan, MD Chief, Diabetes Section, National Institute on Aging
  More Information

Publications:
Responsible Party: National Institute on Aging ( Josephine M. Egan )
Study ID Numbers: AG0056
Study First Received: October 13, 2005
Last Updated: August 28, 2008
ClinicalTrials.gov Identifier: NCT00239707  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
insulin sensitivity
blood sugar

Study placed in the following topic categories:
Gastric Inhibitory Polypeptide
Metabolic Diseases
Diabetes Mellitus, Type 2
Benzocaine
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009