GIP: Glucose-dependent Insulinotropic Peptide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00239707
First received: October 13, 2005
Last updated: November 27, 2013
Last verified: November 2013
  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: GIP
Drug: Modified GIP
Drug: Normal Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of GIP / GIP Analog in Type 2 Diabetes After a Meal

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00239707     History of Changes
Other Study ID Numbers: AG0056
Study First Received: October 13, 2005
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
insulin sensitivity
blood sugar

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastric Inhibitory Polypeptide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014