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| Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University Merck |
| Information provided by: | Albert Einstein College of Medicine of Yeshiva University |
| ClinicalTrials.gov Identifier: | NCT00609154 |
Purpose
The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood. We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.
| Condition | Intervention | Phase |
|
Type 2 Diabetes |
Drug: glucagon like peptide-1 Drug: glucose control |
Phase I |
| MedlinePlus related topics: | Diabetes |
| Drug Information available for: | Insulin Dextrose Glucagon-like peptide 1 Glucagon |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates |
| Estimated Enrollment: | 16 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A: Experimental
Type 2 diabetes
|
Drug: glucagon like peptide-1
GLP-1 1 pmole/kg/min
Drug: glucose control
glucose without GLP-1
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B: Experimental
non diabetic control, matched
|
Drug: glucagon like peptide-1
GLP-1 1 pmole/kg/min
Drug: glucose control
glucose without GLP-1
|
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Type 2 Diabetes Non diabetic, weight, sex, age matched
Exclusion Criteria:
TZD, metformin, Exenatide, sitagliptin CHF, CAD CRF Anemia
Contacts and Locations| Contact: Cynthia Rivera, RN | 718-430-2446 | carivera@aecom.yu.edu |
| United States, New York | |||||
| Albert Einstein College of Medicinie | Recruiting | ||||
| Bronx, New York, United States, 10461 | |||||
| Contact: Cynthia Rivera, RN 718-430-2446 carivera@aecom.yu.edu | |||||
| Principal Investigator: Daniel Stein, MD | |||||
| Albert Einstein College of Medicine of Yeshiva University |
| Merck |
| Principal Investigator: | Daniel Stein, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
| Responsible Party: | Albert Einstein College of Medicine ( Daniel T. Stein, MD ) |
| Study ID Numbers: | 1999-041, Sub-study 4 |
| First Received: | January 23, 2008 |
| Last Updated: | February 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00609154 |
| Health Authority: | United States: Food and Drug Administration; United States: Department of Health and Human Services; United States: Institutional Review Board |
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