|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| National Institute on Aging, Clinical Research Branch | |
| Baltimore, Maryland, United States, 21225 | |
| Principal Investigator: | Josephine Egan, MD | Chief, Diabetes Section, National Institute on Aging |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
insulin sensitivity blood sugar |
|
Metabolic Diseases Gastric Inhibitory Polypeptide Hormone Antagonists Diabetes Mellitus Benzocaine Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases |
Hormones Insulin Diabetes Mellitus, Type 2 Incretins Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Metabolic Diseases Gastric Inhibitory Polypeptide Physiological Effects of Drugs Diabetes Mellitus Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Endocrine System Diseases |
Hormones Pharmacologic Actions Therapeutic Uses Diabetes Mellitus, Type 2 Incretins Glucose Metabolism Disorders |