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Patterns and natural history of insulin secretion in islet cell transplant recipients and controls Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Patterns and natural history of insulin secretion in islet cell transplant recipients and controls conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Patterns and natural history of insulin secretion in islet cell transplant recipients and controls Clinical research trials and Patterns and natural history of insulin secretion in islet cell transplant recipients and controls health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Patterns and natural history of insulin secretion in islet cell transplant recipients and controls. Patterns and natural history of insulin secretion in islet cell transplant recipients and controls Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Patterns and natural history of insulin secretion in islet cell transplant recipients and controls clinical trial. Participants oftentimes recieve the most expert healthcare available for their Patterns and natural history of insulin secretion in islet cell transplant recipients and controls condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Patterns and natural history of insulin secretion in islet cell transplant recipients and controls  Patterns and natural history of insulin secretion in islet cell transplant recipients and controls
Patterns and natural history of insulin secretion in islet cell transplant recipients and controls
For Condition: Diabetes Mellitus
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Juvenile Diabetes Research Foundation
Synopsis: This grant is to study patients that have received a kidney transplant AND an Islet Cell transplant and to discover how the transplant is functioning. We will seek to have several patients who have had a kidney transplant but do NOT have either type of diabetes. These patients will serve as the "control group" since they will also be on immunosuppressive medications but are not affected by abnormal blood sugars. This will allow investigators to develop an understanding of how these immunosuppressive medications affect glucose metabolism (blood sugar levels) and insulin utilization (how the body uses insulin).
Details: If Islet Cell transplants are to become a reasonable treatment alternative for patients with type 1 diabetes, there must be knowledge about how the islet cells function after transplant {islet cells are responsible for making the insulin the body needs in order to control blood sugar). This knowledge would allow for improvements in the islet cell transplant procedure itself, as well as possible alterations of the immunosuppressive medications (drugs that prevent rejection) that are prescribed. There are two basic kinds of diabetes, type 1 (formally known as Insulin Dependent or Juvenile diabetes) and type 2 (formally known as Adult-Onset or Non-insulin dependent) diabetes. The patients in this study will be affected by type 1 diabetes. After the transplant, it is hoped they will no longer need insulin injections. It is possible patients may need to take pioglitizone and/or metformin, however, this will be prescribed in Project 1, if needed. The medications used for this study include: C-peptide. This is a synthetic product (not from human or animal sources) that is man-made and identical to the C-peptide made by the body. C-peptide is made at the same time as insulin, one molecule of insulin equals one molecule C-peptide. By giving C-peptide that is synthetic, researchers can measure how the C-peptide breaks down in the body, which could then be related to how insulin breaks down in the body. Somatostatin will also be used during the same test as the C-peptide. While receiving Somatostatin, the production of insulin by the patient will be stopped. This medication will only be given for 4 hours and the blood sugar will be monitored during the entire procedure. Insulin & Glucose will also be given by IV during certain tests to regulate the blood sugar. Blood sugars will be maintained within a certain level and this will be achieved through the administration of insulin and/or glucose. The patient's blood sugar will be monitored at frequent intervals throughout the various procedures.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Female
Protocol Entry Criteria: Type 1 diabetics that have received a kidney transplant as well as (under Project 1) Islet Cell Transplant. A control group of 8 kidney transplant recipients who do not have diabetes will also be sought. Age range for both groups is expected to fall in the 25-50 year/old range based upon statistical data, although those between the ages of 18 and 65 may also qualify.
Total Enrollment:
Location and Contact Information:
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Kenneth Polonsky 314-362-8061
Additional Information:
Study ID Numbers: NCRR-M01RR00036-0779;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018122
Other Diabetes Mellitus Studies:
1. Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT
2. Genetic Influence on Susceptibility to Type 1 Diabetes Mellitus
3. Screening adolescents for type 2 diabetes mellitus in a community clinic
4. Coronary Artery Risk Development in Young Adults (CARDIA)
5. Multi-Ethnic Study of Atherosclerosis (MESA)
Related Studies:
Other Diabetes Mellitus Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Patterns and natural history of insulin secretion in islet cell transplant recipients and controls
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